MAUDE Adverse Event Report: COOK IRELAND LTD RESONANCE STENT SET; FAD STENT, URETERAL

Catalog Number UNKNOWN

Device Problems Fracture (1260); Solder Joint Fracture (2324)

Patient Problems Sepsis (2067); Respiratory Failure (2484); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

As initially reported to customer relations via emailed brief information and device image: physicians comments: ¿retained resonance stent referred to me and this is what it looked like out¿, ¿when i first put my camera in i could see the wire out of the uo¿, ¿the previous urologist attempted to remove it and not sure what type of manipulation he did.¿.

Manufacturer Narrative

It can be noted that the based on the additional information this event meets the criteria of an fda ¿serious injury¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ section 2.13 and 2.15.As the patient required bilateral nephrostomy tubes, multiple admissions, tracheostomy secondary to respiratory failure from sepsis from a urinary source as a result of the difficult stent removal.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Initial complaint details: as initially reported to customer relations via emailed brief information and device image: physicians comments: ¿retained resonance stent referred to me and this is what it looked like out¿ ¿when i first put my camera in i could see the wire out of the uo¿ ¿the previous urologist attempted to remove it and not sure what type of manipulation he did¿ this follow-up report is being submitted due to the receipt of additional information on (b)(6) 2020 as follows: 1.Did any unintended section of the device remain inside the patient¿s body? no.If yes, please describe.The resonance stent was removed in its entirety.2.Was the patient hospitalized or was there prolonged hospitalization? yes, patient required bilateral nephrostomy tubes, multiple admissions, tracheostomy, secondary to respiratory failure from sepsis from urinary source.3.Did the patient require any additional procedures due to this occurrence? yes.If yes, please describe.Patient required both ureteroscopy and pcnl to remove the retained resonance stent 4.Did the product cause or contribute to the need for additional procedures? yes.If yes, please specify additional procedures and provide details.See above 5.Has the complainant reported any adverse effects on the patient due to this occurrence? yes, the patient had numerous medical problems because resonance stent could not be removed.See above 6.Has the complainant reported that the product caused or contributed to the adverse effects? the resonance stent failed and caused obstruction leading to nephrostomy tube placement please specify adverse effects and provide details.

Event Description

Supplemental follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions.

Manufacturer Narrative

1 x unknown rms device of unknown lot number was not returned to cirl for a lab evaluation.Therefore a document based investigation was completed.However the submitted image of the rms stent on removal confirms the inner wire is separated from the coil wire of the stent.As the rpn and lot number of the complaint devices are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution rms-060026-r devices are subjected 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.A review of the manufacturing records for the unknown rms device could not be completed as the lot number was unknown.The instructions for use, which accompanies this device warns of the following ¿patients should be checked at regular intervals utilizing techniques such as abdominal x-ray (kub film).Patients using calcium supplements must be more closely monitored for possible stent encrustation.The stent must be removed if encrustation hampers drainage¿.It may be noted that according to the instructions for use, instructs the user as follows: ¿the stent may be removed using conventional cystoscopic techniques utilizing forceps or grasper.Note: do not force components during removal or replacement.Carefully remove the components if any resistance is encountered.¿ a final warning in the instructions for use indicates that: ¿individual variations of interaction between stents and the urinary system are unpredictable¿ there is not sufficient evidence to suggest that the user did not follow the instructions for use.A definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient condition related.It maybe as the result of compression by a tight stricture or encrustation that may have caused the stent to be difficult to remove on the first attempt.The physician indicated the inner wire was separated before withdrawal.However this was the second attempt to remove the stent so the wire separation/break may have occurred as a result of the first attempted removal.There are no details available on the first procedure, it is not known why the stent was being removed or how long it was in place.There are no details available as to the length of time between the two procedures.It is likely excessive force may have caused the stent to break on during the first removal attempt.Complaint is confirmed based on the customer¿s testimony and is confirmed as the failure was verified in the image.Yes, patient required bilateral nephrostomy tubes, multiple admissions, tracheostomy, secondary to respiratory failure from sepsis from urinary source.Patient required both ureteroscopy and pcnl to remove the retained resonance stent.Complaints of this nature will continue to be monitored for emerging trends.

• Brand Name: RESONANCE STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10303348
• MDR Text Key: 199905021
• Report Number: 3001845648-2020-00442
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K063742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/24/2020
• Initial Date FDA Received: 07/21/2020
• Supplement Dates Manufacturer Received: 06/24/2020; 06/24/2020
• Supplement Dates FDA Received: 08/27/2020; 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death