| Catalog Number UNKNOWN |
| Device Problem
Complete Blockage (1094)
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| Patient Problem
Obstruction/Occlusion (2422)
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| Event Date 04/13/2021 |
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Event Type
Injury
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Manufacturer Narrative
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Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
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Event Description
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The resonance stent was noted to be occluded.Hydronephrosis was noted in the left kidney.The stent was removed with cystoscopic graspers and a plastic stent was placed.Updated information: patient had two failed 6x24 resonance stents in her left ureter that were replaced with two more 6x24 resonance stents.Indwelling time is approximately 6 months.Did any unintended section of the device remain inside the patient¿s body? no, was the patient hospitalized or was there prolonged hospitalization? no, did the patient require any additional procedures due to this occurrence? no, did the product cause or contribute to the need for additional procedures? no, has the complainant reported any adverse effects on the patient due to this occurrence? yes, has the complainant reported that the product caused or contributed to the adverse effects? yes, please specify adverse effects and provide details.Hydronephrosis of the left kidney due to lack of drainage.
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Manufacturer Narrative
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Investigation is still pending.A follow up mdr will be submitted, to include the investigation conclusions.
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Event Description
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Supplemental report being submitted, due to completion of lab evaluation on (b)(6) 2021.
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Event Description
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Supplemental report being submitted due to completion of lab re-evaluation on (b)(6) 2022 x3 units of ureteral stent of unknown rpn and unknown lot number were returned opened without the original packaging.With the information provided, a physical examination and document-based investigation was conducted.Visual inspection: (b)(4) slight encrustation observed on the pigtail.Slight discoloration.The proximal end is out of shape does not lay flat on the surface.(b)(4) (first) significant encrustation noted (second) slight encrustation noted.Kink noted on the body of the stent approx.1cm from the pigtail curl.Functional inspection: n/a.No impact to ae assessment.Follow-up mdr scheduled to include the lab re-evaluation.
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Manufacturer Narrative
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Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
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Manufacturer Narrative
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Device evaluation the resonance metallic ureteral stent device of unknown lot number involved in this complaint was returned for evaluation, without the original packaging.With the information provided, a physical examination and document-based investigation was conducted.Lab evaluation the device related to this occurrence underwent a laboratory evaluation on the (b)(6) 2021.On evaluation of the device pr328764-1 slight encrustation observed on the pigtail.Slight discoloration.The proximal end is out of shape does not lay flat on the surface.Pr328764 -2 (a) significant encrustation noted.Pr328764-2 (b) slight encrustation noted.Kink noted on the body of the stent approx.1cm from the pigtail curl.It should be noted the an extra rms stent was returned for evaluation per customer input "dr.Morgan replacing the two failed stents in the patient¿s left ureter but i can¿t remember the complications with the right stent.I don¿t recall sending it back for evaluation.I can¿t say with complete certainty that the only affected stents were the two on the patient¿s left side." all returned device were evaluated and included in the lab evaluation notes it should be noted the lab notes were updated and included in the returned product notes.The notes were re-evaluated on the (b)(6) 2022.Document review as the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all resonance metallic ureteral stent devices are subject to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.It should be noted that the instructions for use (ifu0020) states the following: ¿potential adverse events associated with indwelling ureteral stents include: diminished urine drainage/ stent occlusion¿.¿warnings patients should be checked at regular intervals utilizing techniques such as abdominal x-ray (kub film).Patient using calcium supplements must be more closely monitored for possible stent encrustation.The stent must be removed if encrustation hampers drainage¿.There is no sufficient evidence to suggest the user did not follow the ifu.A definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to the patient¿s condition.The stent had evidence of encrustation present; this encrustation would have blocked the lumen of stent causing them to cease draining.The hydronephrosis could have created an environment within the patient where encrustation could have developed on the stents due to interactions with the patient¿s anatomy.As per instructions for use, diminished urine drainage/ stent occlusion/ stent encrustation are listed as a complication following the placement of the device.Summary complaint is confirmed based on the customers testimony as the clinical setting that could impact on the functionality of the device cannot be replicated in the laboratory.According to the initial reporter, the patient experienced hydronephrosis of the left kidney due to lack of drainage.Complaints of this nature will continue to be monitored for potential emerging trends.
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Event Description
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Supplemental report is being submitted due to the completion of the investigation.
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Event Description
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Supplemental follow-up report is being submitted due to the receipt of additional information.Additional information received on 13-jul-22 as follows: 1.What was the length of the indwell time? n/a 2.What disease mode was the physician trying to treat? chronic ureteral obstruction 3.Was the stent stored in strong light (e.G.In a in a pyxis machine) or in direct sunlight? no 4.If yes, please detail where the device was stored 5.What was the target location for the stent? ureter 6.Was there difficulty advancing the stent to the target location? n/a, 7.How often was the stent checked during the in-dwelling time? unknown 8.What is the source of the extrinsic compression? n/a 9.If other, please specify 10.If caused by a tumor, what is the tumor type? n/a 11.What is the stage of the tumor? n/a 12.Was the patient using calcium supplementation? n/a 13.Was force required to remove the stent? n/a 14.Was encrustation evident on the stent? n/a 15.Did the patient require any additional procedures as a result of this event? n/a 16.What intervention (if any) was required? unknown 17.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a 18.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? n/a 19.If yes, please specify what was observed and where on the device it was observed.
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Manufacturer Narrative
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Device evaluation the resonance metallic ureteral stent device of unknown lot number involved in this complaint was returned for evaluation, without the original packaging.With the information provided, a physical examination and document-based investigation was conducted.Lab evaluation the device related to this occurrence underwent a laboratory evaluation on the 19th august 2021.On evaluation of the device pr (b)(4) slight encrustation observed on the pigtail.Slight discoloration.The proximal end is out of shape does not lay flat on the surface.Pr (b)(4)(a) significant encrustation noted.Pr (b)(4) (b) slight encrustation noted.Kink noted on the body of the stent approx.1cm from the pigtail curl.It should be noted the an extra rms stent was returned for evaluation per customer input "dr.(b)(6) replacing the two failed stents in the patient¿s left ureter but i can¿t remember the complications with the right stent.I don¿t recall sending it back for evaluation.I can¿t say with complete certainty that the only affected stents were the two on the patient¿s left side." all returned device were evaluated and included in the lab evaluation notes it should be noted the lab notes were updated and included in the returned product notes.The notes were re-evaluated on the 4th april 2022.Refer to "plastics lab evaluations attendance 04 apr 2022.Msg" for the revised lab evaluation photos and "plastics lab evaluations attendance 04 apr 2022.Msg" for the lab attendance.Document review as the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all resonance metallic ureteral stent devices are subject to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.It should be noted that the instructions for use (ifu0020) states the following: ¿potential adverse events associated with indwelling ureteral stents include: diminished urine drainage/ stent occlusion¿.¿warnings patients should be checked at regular intervals utilizing techniques such as abdominal x-ray (kub film).Patient using calcium supplements must be more closely monitored for possible stent encrustation.The stent must be removed if encrustation hampers drainage¿ there is no sufficient evidence to suggest the user did not follow the ifu.Image review n/a impression n/a root cause review a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to the patient¿s condition.The stent had evidence of encrustation present; this encrustation would have blocked the lumen of stent causing them to cease draining.The hydronephrosis could have created an environment within the patient where encrustation could have developed on the stents due to interactions with the patient¿s anatomy.As per instructions for use, diminished urine drainage/ stent occlusion/ stent encrustation are listed as a complication following the placement of the device.Summary complaint is confirmed based on the customers testimony as the clinical setting that could impact on the functionality of the device cannot be replicated in the laboratory.According to the initial reporter, the patient experienced hydronephrosis of the left kidney due to lack of drainage.Complaints of this nature will continue to be monitored for potential emerging trends.
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