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

Model Number G34111

Device Problem No Flow (2991)

Patient Problem Failure of Implant (1924)

Event Date 07/06/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient was implanted cook stent successfully on (b)(6) 2019 in left ureter.There is no bleeding detected and the urine is normal after implantation.Second day after procedure patient has no urine and increased creatinine.User conducted nephrostomy at left ureter, and nephrostomy tube drainage well.The urine became normal and creatinine decreased after nephrostomy.In the following 3 days user tried several times to clamp the nephrostomy tube to see if the stent is unobstructed, but no urine comes out.User implanted another same stent to replace the one implanted last time 2 weeks after.There was no bleeding detected and urine is normal, and the nephrostomy tube was removed as well.Urine is normal each after the procedure.Fda mdr reporting required: 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 experienced nephrostomy after stent implantation and surgical intervention was required to remove the non-functioning stent, also reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent does not drain'.Patient experienced nephrostomy after stent implantation.

Manufacturer Narrative

Device evaluation the rms-060026-r device of lot number c1605840 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) 2019.On evaluation of the device a slight residue that was dark in colour was observed in the middle of the stent.The middle of the stent was cut and uncoiled in the laboratory and residual of a blood/tissue like substance was observed inside the stent.Document review 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 c1605840 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 c1605840.There is no evidence to suggest that the customer did not follow the instructions for use (ifu0020-16).It should be noted that the ifu states the following: ¿change in urine viscosity may hamper drainage.¿ it should also be noted that the ifu lists diminished urine drainage / stent occlusion as a known potential adverse event.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 patient condition related (blocked by tissue), as per instructions for use, diminished urine drainage/ stent occlusion are listed as a complication following the placement of the device.Summary: complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, the patient required a nephrostomy tube to be placed two days after the stent was placed and subsequent stent removal and replacement after two weeks.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Patient was implanted cook stent successfully on (b)(6) 2019 in left ureter.There is no bleeding detected and the urine is normal after implantation.Second day after procedure patient has no urine and increased creatinine.User conducted nephrostomy at left ureter, and nephrostomy tube drainage well.The urine became normal and creatinine decreased after nephrostomy.In the following 3 days user tried several times to clamp the nephrostomy tube to see if the stent is unobstructed, but no urine comes out.User implanted another same stent to replace the one implanted last time 2 weeks after.There was no bleeding detected and urine is normal, and the nephrostomy tube was removed as well.Urine is normal each after the procedure.Fda mdr reporting required: 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 had nephrostomy tube place after stent stopped draining and surgical intervention was required to remove the non-functioning stent, also reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent does not drain' and "stent fracture/breakage/uncoiling".

• Brand Name: RESONANCE STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8906981
• MDR Text Key: 157097334
• Report Number: 3001845648-2019-00422
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002341118
• UDI-Public: (01)10827002341118(17)220418(10)C1605840
• 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
• Report Date: 08/19/2019

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 Expiration Date: 04/18/2022
• Device Model Number: G34111
• Device Catalogue Number: RMS-060026-R
• Device Lot Number: C1605840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/19/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 08/19/2019
• Supplement Dates Manufacturer Received: 07/24/2019
• Supplement Dates FDA Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 56