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

Model Number	G34111
Medical Device Problem Codes	Difficult to Remove (1528); Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
As initially reported to customer relations via district managers email: we just had another metallic stent that could not be removed.The physician was eventually able to get it out.Additional patient outcome details have been requested but have not been received to date.No adverse effects have currently been reported.
Additional Manufacturer Narrative
Section b.5 has been updated to include the additional complaint information received on 23-jun-2020.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Additional information received as follows on 23-june-2020.Per physician filling out remainder of complaint form: had safety wire in place.Attempted to remove stent with flexible grasper but was not unable to uncoil distal pigtail.Pulled with a decent amount of force several times but wasn't able to uncurl with the resistance she was applying.She worried she would avulse the ureter by pulling too hard.Made the decision to mix saline with viscous lidocaine jelly and inject up the ureter through a ureteral catheter.She then pulled with more force and was able to extract the device.Ultimately, the device came out fine and in one piece but was slightly curled on the distal end.She determined that the resistance was that the pigtail just wouldn't uncurl.After the device was removed from the patient, she was able to uncurl the pigtail with her fingers.Shot retrograde and there was no extravasation.
Event or Problem Description
This follow up report is being submitted due to the completion of this investigation.Initial report details: as initially reported to customer relations via district managers email: we just had another metallic stent that could not be removed.The physician was eventually able to get it out.Additional patient outcome details have been requested but have not been received to date.No adverse effects have currently been reported.Additional information received as follows on (b)(6) 2020 per physician filling out remainder of complaint form: had safety wire in place.Attempted to remove stent with flexible grasper but was not unable to uncoil distal pigtail.Pulled with a decent amount of force several times but wasn't able to uncurl with the resistance she was applying.She worried she would avulse the ureter by pulling too hard.Made the decision to mix saline with viscous lidocaine jelly and inject up the ureter through a ureteral catheter.She then pulled with more force and was able to extract the device.Ultimately, the device came out fine and in one piece but was slightly curled on the distal end.She determined that the resistance was that the pigtail just wouldn't uncurl.After the device was removed from the patient, she was able to uncurl the pigtail with her fingers.Shot retrograde and there was no extravasation.
Additional Manufacturer Narrative
1 x rms-060026-r of lot number c1535119 was not returned to cirl for a lab evaluation.Therefore a document based investigation was completed.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 rms-060026-r of lot number c1535119 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1535119.It should be noted that the instructions for use states the following: ¿warnings these stents are not intended as permanent indwelling devices.The stent must not remain indwelling more than twelve (12) months.If the patient¿s status permits, the stent may be replaced with a new stent.Patients should be checked at regular interval 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¿ it may be noted that according to the instructions for use,, the user is instructed that ¿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.¿ there is evidence to suggest that the customer did not follow the instructions for use.A definitive root cause could be attributed to the stent in place for longer than the recommended indwell time.From the information provided it is known that the stent was left indwelling for 14 months.The ifu instructs that the stent should not remain in place for more than 12 months.The implant date occurred on the (b)(6) 2019 and the explant then occurred on the (b)(6) 2020.This increase in indwell time could have resulted in either stent encrustation or tissue ingrowth, inhibiting its removal as a result of this extended dwell time.Complaint is confirmed based on customer testimony.According to the information reported, the patient did not experience any adverse effects due to this occurrence.Shot retrograde was performed and there was no extravasation according to the physician.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: RESONANCE STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10157019
• Report Number: 3001845648-2020-00354
• Device Sequence Number: 3300529
• Product Code: FAD
• UDI-Device Identifier: 10827002341118
• UDI-Public: (01)10827002341118(17)210830(10)C1535119
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K063742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/30/2021
• Device Model Number: G34111
• Device Catalogue Number: RMS-060026-R
• Device Lot Number: C1535119
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/19/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/02/2020
• Supplement Date Received by Manufacturer: 06/02/2020; 06/02/2020
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 07/14/2020; 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention