| Catalog Number UNKNOWN |
| Device Problems
Device remains implanted (1526); Difficult to Remove (1528)
|
| Patient Problems
Surgical procedure, additional (2564); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
|
| Event Date 03/16/2015 |
|
Event Type
Injury
|
|
Event Description
|
|
The physician indicated that the pig tail would not straighten out, therefore the sent could not be removed.The pt was to be sent to another medical facility to have the stent removed percutaneously.The stent remained inside the pt's body.It is unk if the pt experienced any adverse effects due to this occurrence.No further info in relation to this event has been rec'd to date.
|
| |
|
Manufacturer Narrative
|
|
Prod name was provided but the exact prod code and lot info is unk.Length of the stent is also unk.The device involved in the complaint was not available to be returned for eval.With info provided a document based investigation was carried out.The complaint was confirmed based on the customers testimony.As the device has not been returned the cause of the complaint could not be conclusively determined.The lot number of the device in this complaint was not provided therefore it was not possible to conduct a review of the device mfg records.Rms devices are used for temporary stenting of the ureter in adult pts with extrinsic ureteral obstruction.These devices are intended for one-time use.As per instruction for use, users are cautioned as follows: "individual variations of interaction between stents and the urinary system are unpredictable." a warning on the instructions for use also advises the following: "pts should be checked at regular intervals utilizing techniques such as abdominal x-ray (kub film)." prior to dist all resonance stent devices are subjected to visual inspection and functional checks to ensure device integrity.The pt was to be sent to another medical facility to have the stent removed percutaneously.It is unk if the pt experienced any adverse effects due to this occurrence.No further info in relation to this event has been rec'd to date.Complaints of this nature will continue to be monitored for potential emerging trends.
|
| |
|
Manufacturer Narrative
|
|
Additional information received is as follows: 'there was a second attempt to remove the rms stent via cystoscopy, but this was also unsuccessful.The patient was referred to (b)(6) for percutaneous stent removal.The md at (b)(6) stated that the removal procedure is scheduled for end of (b)(6).The md also stated that the stent is curled in the ureter and advised that the patient may need removal of kidney, however this is not directly related to stent'.Product name was provided but the exact product code and lot information is unknown.The length of the stent is also unknown.The complaint device remains implanted in the patient with the information provided a document based investigation was carried out.The lot number of the device involved in this complaint was not provided therefore it was not possible to conduct a review of the device manufacturing records.The complaint was confirmed based on the customers testimony.As the device has not been returned, the cause of the complaint could not be conclusively determined.Rms devices are used for temporary stenting of the ureter in adult patients with extrinsic ureteral obstruction.These devices are intended for one-time use.As per instructions for use, users are cautioned as follows "individual variations of interaction between stents and the urinary system are unpredictable." a warning on the instructions for use also advises the following: "patients should be checked at regular intervals utilizing techniques such as abdominal x-ray (kub film)." prior to distribution, all resonance stent devices are subjected to visual inspection and functional checks to ensure device integrity.Complaints of this nature will continue to be monitored for potential emerging trends.
|
| |
|
Event Description
|
|
This follow up report is being submitted based on the receipt of additional information regarding the patient status and retrieval attempts.It should be noted that these details do not impact the evaluation conclusions previously submitted in relation to this event.Initial complaint information received was as follows.The physician indicated that the pig tail would not straighten out, therefore the stent could not be removed.The patient was to be sent to another medical facility to have the stent removed percutaneously.
|
| |
|
Manufacturer Narrative
|
|
Additional information received is as follows: surgery scheduled for (b)(6) 2015 to have the stent removed.Additional information provided by district manager on (b)(6) 2015: "stent was removed from patient today.The surgeon established percutaneous access to the kidney where the stent loop was visible but stent would not pull out.Surgeon accessed the lower loop of the stent via a flexible cystoscope and found the lower loop of the stent to be curled in the urethra.It appeared the stent was embedded or had adhered to the sidewall of the urethra per the surgeon.Surgeon finally uncurled the lower loop in the urethra using a cook ncircle basket while a second surgeon accessed the upper loop of the stent via the nephroscope - the stent was then removed percutaneously.Surgeon noted urethral damage where the stent was attached to the sidewall - tissue is stuck to the stent.".
|
| |
|
Event Description
|
|
This follow up report is being submitted based on the receipt of additional information regarding the stent retrieval attempt.It should be noted that these details do not impact the evaluation conclusions previously submitted in relation to this event.Initial complaint information received was as follows: the physician indicated that the pig tail would not straighten out, therefore the stent could not be removed.The stent remained inside the patient's body.The patient is being sent to another medical facility to have the stent removed percutaneously.The patient's kidney has lost approximately 60% function and the surgeon feels this is due to the combination of the metallic stent and polymer stent having been in the patient for so long.Additional information: surgery scheduled for (b)(6) 2015 to have the stent removed.Additional information provided by district manager on (b)(6) 2015 was as follows: "stent was removed from patient today.The surgeon established percutaneous access to the kidney where the stent loop was visible but stent would not pull out.Surgeon accessed the lower loop of the stent via a flexible cystoscope and found the lower loop of the stent to be curled in the urethra.It appeared the stent was embedded or had adhered to the sidewall of the urethra per the surgeon.Surgeon finally uncurled the lower loop in the urethra using a cook ncircle basket while a second surgeon accessed the upper loop of the stent via the nephroscope - the stent was then removed percutaneously.Surgeon noted urethral damage where the stent was attached to the sidewall - tissue is stuck to the stent.".
|
| |
|
Manufacturer Narrative
|
|
The customer reported the following complaint issue: ¿the physician was unable to remove the stent.The physician indicated that the pig tail would not straighten out, therefore the stent could not be removed.The patient is being sent to another medical facility to have the stent removed percutaneously.¿ dm is requesting information regarding the procedure at other facility to see if it is possible that she can pick up the stent to return to cook for investigation upon removal.On (b)(6) 2015 the district manager provided the following additional information: ¿stent was removed from pt today by dr (b)(6).The surgeon established percutaneous access to the kidney where the stent loop was visible but stent would not pull out.Surgeon accessed the lower loop of the stent via a flexible cystoscope and found the lower loop of the stent to be curled in the urethra.It appeared the stent was embedded or had adhered to the sidewall of the urethra per the surgeon.Surgeon finally uncurled the lower loop in the urethra using a cook n circle basket while a second surgeon accessed the upper loop of the stent via the nephroscope - the stent was then removed percutaneously.Surgeon noted urethral damage where the stent was attached to the sidewall - tissue is stuck to the stent.I am mailing stent today.¿ it was indicated that the device was due to be returned to cirl for evaluation.Device was returned 18-aug-2015.Once evaluation is available, a follow up report will be submitted.Product name was provided but the exact gpn and lot # is unknown.Length of the stent is unknown.The device involved in the complaint was not available initially for evaluation.With the information provided a document based investigation was carried out.The complaint was confirmed based on the customers testimony.As the device has not been returned the cause of the complaint could not be conclusively determined.Prior to distribution all resonance stent devices are subjected to visual inspection and functional checks to ensure device integrity.As the lot number of the device involved in this complaint was not provided, it was not possible to conduct a review of the device manufacturing records for this device.Rms devices are used for temporary stenting of the ureter in adult patients with extrinsic ureteral obstruction.These devices are intended for one-time use.As per instructions for use , users are cautioned as follows: ¿individual variations of interaction between stents and the urinary system are unpredictable.¿ a warning on the instructions for use also advises the following: ¿patients should be checked at regular intervals utilizing techniques such as abdominal x-ray (kub film).¿ complaints of this nature will continue to be monitored for emerging trends.The customer reported the following complaint issue: ¿the physician was unable to remove the stent.The physician indicated that the pig tail would not straighten out, therefore the stent could not be removed.The patient is being sent to another medical facility to have the stent removed percutaneously.¿ dm is requesting information regarding the procedure at other facility to see if it is possible that she can pick up the stent to return to cook for investigation upon removal.On (b)(6) 2015 the district manager provided the following additional information: ¿stent was removed from pt today by dr (b)(6).The surgeon established percutaneous access to the kidney where the stent loop was visible but stent would not pull out.Surgeon accessed the lower loop of the stent via a flexible cystoscope and found the lower loop of the stent to be curled in the urethra.It appeared the stent was embedded or had adhered to the sidewall of the urethra per the surgeon.Surgeon finally uncurled the lower loop in the urethra using a cook ncircle basket while a second surgeon accessed the upper loop of the stent via the nephroscope - the stent was then removed percutaneously.Surgeon noted urethral damage where the stent was attached to the sidewall - tissue is stuck to the stent.I am mailing stent today.¿ it was indicated that the device was due to be returned to cirl for evaluation.Device was returned 18-aug-2015.Once evaluation is available, a follow up report will be submitted.Product name was provided but the exact gpn and lot # is unknown.Length of the stent is unknown.The device involved in the complaint was not available initially for evaluation.With the information provided a document based investigation was carried out.The complaint was confirmed based on the customers testimony.As the device has not been returned the cause of the complaint could not be conclusively determined.Prior to distribution all resonance stent devices are subjected to visual inspection and functional checks to ensure device integrity.As the lot number of the device involved in this complaint was not provided, it was not possible to conduct a review of the device manufacturing records for this device.Rms devices are used for temporary stenting of the ureter in adult patients with extrinsic ureteral obstruction.These devices are intended for one-time use.As per instructions for use , users are cautioned as follows: ¿individual variations of interaction between stents and the urinary system are unpredictable.¿ a warning on the instructions for use also advises the following: ¿patients should be checked at regular intervals utilizing techniques such as abdominal x-ray (kub film).¿ complaints of this nature will continue to be monitored for emerging trends.
|
| |
|
Event Description
|
|
The physician was unable to remove the stent.The physician indicated that the pig tail would not straighten out, therefore the stent could not be removed.The patient is being sent to another medical facility to have the stent removed percutaneously.Dm is requesting information regarding the procedure at other facility to see if it is possible that she can pick up the stent to return to cook for investigation upon removal.Additional information provided by the dm 20apr2015: "the most up to date information i have is that dr.(b)(6) went back a second time to attempt to remove the rms stent and was not able to remove via cycstoscope.The pt has been referred to (b)(6) medical system to have the stent removed via percutaneous removal.I will follow-up with (b)(6)" additional information provided by the dm 07may2015: "stent is still in the pt.I spoke to md at (b)(6) yesterday and was advised pt is scheduled for end of (b)(6).Md advised the stent is curled in the ureter.Md advised pt may need removal of kidney not directly related to stent she said.I will get the stent and ship to cook once removed from pt." additional information provided by the dm 18jun2015: "i spoke with the surgeon and she advised the patient is scheduled for a percutaneous procedure to remove the stent at the end of (b)(6); the stent is still inside the pt.The surgeon advised the kidney has lost approx.60% function as feels this is due to the combination of the metallic stent and polymer stent having been in for so long.I will advise of further information as i know.I plan to be in the or when the stent is removed." additional information provided by dm on 20jul2015: "the patient has a scheduled surgery tomorrow to have the stent removed.I will call you with additional information when the procedure is over." additional information provided by dm on 21jul2015: "stent was removed from patient today by dr.(b)(6) at (b)(6) in (b)(6).The surgeon established percutaneous access to the kidney where the stent loop was visible but stent would not pull out.Surgeon accessed the lower loop of the stent via a flexible cystoscope and found the lower loop of the stent to be curled in the urethra.It appeared the stent was embedded or had adhered to the sidewall of the urethra per the surgeon.Surgeon finally uncurled the lower loop in the urethra using a cook n circle basket while a second surgeon accessed the upper loop of the stent via the nephroscope - the stent was then removed percutaneously.Surgeon noted urethral damage where the stent was attached to the sidewall - tissue is stuck to the stent.I am mailing stent today.".
|
| |
|
Manufacturer Narrative
|
|
One (1) x rms stent of unknown lot was returned for evaluation.It was not returned in its original packaging and was open on receipt.On evaluation of the returned stent, no damage was observed.The curls of the stent opened freely as per the design intent.Tissue encrustation was present, however it is expected to see slight tissue ingrowth.The exact rpn and lot # is unknown.A definitive cause for the customer¿s complaint was unable to be determined because the actual use conditions could not be duplicated in the laboratory setting.The complaint was confirmed based on the customers testimony.Prior to distribution all resonance stent devices are subjected to visual inspection and functional checks to ensure device integrity.As the lot number of the device involved in this complaint was not provided, it was not possible to conduct a review of the device manufacturing records for this device.Rms devices are used for temporary stenting of the ureter in adult patients with extrinsic ureteral obstruction.These devices are intended for one-time use.As per instructions for use , users are cautioned as follows: ¿individual variations of interaction between stents and the urinary system are unpredictable.¿ a warning on the instructions for use also advises the following: ¿patients should be checked at regular intervals utilizing techniques such as abdominal x-ray (kub film).¿ complaints of this nature will continue to be monitored for emerging trends.
|
| |
|
Event Description
|
|
This follow up report is being submitted due to the evaluation of the device involved in this incident.Original complaint information submitted as follows: the physician was unable to remove the stent.The physician indicated that the pig tail would not straighten out, therefore the stent could not be removed.The patient is being sent to another medical facility to have the stent removed percutaneously.Dm is requesting information regarding the procedure at other facility to see if it is possible that she can pick up the stent to return to cook for investigation upon removal.Additional information provided by the dm 20apr2015: "the most up to date information i have is that dr.(b)(6) went back a second time to attempt to remove the rms stent and was not able to remove via cycstoscope.The pt has been referred to ut southwestern medical system to have the stent removed via percutaneous removal.I will follow-up with (b)(6)" additional information provided by the dm 07may2015: "stent is still in the pt.I spoke to md at (b)(6) yesterday and was advised pt is scheduled for end of may.Md advised the stent is curled in the ureter.Md advised pt may need removal of kidney not directly related to stent she said.I will get the stent and ship to cook once removed from pt." additional information provided by the dm 18jun2015: "i spoke with the surgeon and she advised the patient is scheduled for a percutaneous procedure to remove the stent at the end of (b)(6); the stent is still inside the pt.The surgeon advised the kidney has lost approx.60% function as feels this is due to the combination of the metallic stent and polymer stent having been in for so long.I will advise of further information as i know.I plan to be in the or when the stent is removed." additional information provided by dm on 20jul2015: "the patient has a scheduled surgery tomorrow to have the stent removed.I will call you with additional information when the procedure is over." additional information provided by dm on 21jul2015: "stent was removed from patient today by dr.(b)(6) at (b)(6).The surgeon established percutaneous access to the kidney where the stent loop was visible but stent would not pull out.Surgeon accessed the lower loop of the stent via a flexible cystoscope and found the lower loop of the stent to be curled in the urethra.It appeared the stent was embedded or had adhered to the sidewall of the urethra per the surgeon.Surgeon finally uncurled the lower loop in the urethra using a cook ncircle basket while a second surgeon accessed the upper loop of the stent via the nephroscope - the stent was then removed percutaneously.Surgeon noted urethral damage where the stent was attached to the sidewall - tissue is stuck to the stent.I am mailing stent today.".
|
| |
|
Manufacturer Narrative
|
|
(b)(4).Exemption number: e2016031.(b)(4).Additional information received is as follows: the patient is scheduled for a percutaneous procedure to remove the stent at the end of july; the stent is still inside the patient.The surgeon advised the kidney has lost approx.60% function and feels this is due to the combination of the metallic stent and polymer stent having been in place for so long.Investigation details: product name was provided but the exact product code and lot information is unknown.The length of the stent is also unknown.The complaint device remains implanted in the patient.With the information provided a document based investigation was carried out.The lot number of the device involved in this complaint was not provided therefore it was not possible to conduct a review of the device manufacturing records.The complaint was confirmed based on the customers testimony.As the device has not been returned, the cause of the complaint could not be conclusively determined.Rms devices are used for temporary stenting of the ureter in adult patients with extrinsic ureteral obstruction.These devices are intended for one-time use.As per instructions for use , users are cautioned as follows: ¿individual variations of interaction between stents and the urinary system are unpredictable.¿ a warning on the instructions for use also advises the following: ¿patients should be checked at regular intervals utilizing techniques such as abdominal x-ray (kub film).¿ prior to distribution all resonance stent devices are subjected to visual inspection and functional checks to ensure device integrity.Complaints of this nature will continue to be monitored for emerging trends.
|
| |
|
Event Description
|
|
This report is being re-submitted electronically to the fda for processing.This follow up report is being submitted based on the receipt of additional information regarding the patient status and retrieval attempts.It should be noted that these details do not impact the evaluation conclusions previously submitted in relation to this event.Initial complaint information received was as follows: the physician indicated that the pig tail would not straighten out, therefore the stent could not be removed.
|
| |
|
Search Alerts/Recalls
|
