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

Model Number G34110

Device Problems Break (1069); Failure to Advance (2524); Material Twisted/Bent (2981)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/23/2020

Event Type  Injury  

Manufacturer Narrative

Complaint device was returned and evaluated on 13-nov-2020: the clear sheath was observed to be damaged and kinked but not broken.The stent was unused and not damaged.The damage to the sheath is consistent with a twisting and pulling force applied by physician to remove device.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

La procedure; under c arm and cystoscope guidance, insertion of terumo 0.035' guidewire without any problem; advanced a 6fr u-cath over the wire guide, removed the guidewire and injected contrast for mapping; insertion of wire guide and remove the u-cath along the cystoscope; rms-060024-r opened, preping and checking, no product defeat found; advanced the pusher and sheath over the wire guide, cannot advance further when reaching the middle of the ureter; resistant experienced not just push, but pull; bigger force used to pull out the pusher and sheath system to remove from patient body; the outer sheath was found broken after that; another procedure arranged after 3 weeks.Patient outcome: ureter bleeding.Additional information received 11-nov-2020 as follows: please refer to the reply below: what is the source of the extrinsic compression? tumor.If caused by a tumor, what is the tumor type? ca colon.What is the stage of the tumor? stage iii.What was used to remove the outer sheath and pusher when it became stuck? manually by doctor¿s turn, twist, pull and push.Please confirm the rms-060024-r was not advanced into the patient? yes, it is not, as the sheath stuck.Was the source of the extrinsic compression located at the middle of the ureter? should be the ca colon caused.

Manufacturer Narrative

The rms-060024-r device of lot number c1753434 involved in this complaint was returned for evaluation without its original packaging.With the information provided, a physical examination and document based investigation was conducted.The clear sheath at the distal end was damaged (not broken) at black tip marker approx.To 3cm-5.5cm.Slight kinks were observed on the sheath from white hub at approx.9 cm.The pusher had slight bends along its length.Stent was unused and no damage was observed.Prior to distribution rms-060024-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-060024-r of lot number c1753434 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 c1753434.The instructions for use, ifu which accompanies this device instructs the end user to "improper handling of the stent prior to insertion into the ureter may harm the functionality of the stent.Bending, stretching or any other type of improper handling may deform the stent.It is important that the stent is handled with care." the instructions for use, ifu which accompanies this device instructs the end user to ¿over a previously placed wire guide, pass introduction catheter and sheath into appropriate position utilizing fluoroscopic guidance or direct vision." ifu instructs the user to use the device with wire guide 0.038" diameter.It may be noted from the initial report that 0.035" diameter wire guide was used, while 0.038" wire guide should have been used as per the ifu.It would not have caused the issue encountered and is not a usage error of the device, product manager has been notified as a precautionary measure.This could have contributed to the resistance; however, as we do not have this information, it is only a possibility.Product manager notified that the incorrect wire guide size was used with the device 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 anatomy.It is possible that sheath got damaged because it was difficult to be advanced past a tight stricture and the compressive forces applied on it in attempting to retrieve it, may have caused the damage to the sheath.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 required additional procedure after three weeks and had ureteral bleeding as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

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

• Brand Name: RESONANCE STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10876238
• MDR Text Key: 220165223
• Report Number: 3001845648-2020-00885
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002341101
• UDI-Public: (01)10827002341101(17)230824(10)C1753434
• 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: 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 Expiration Date: 08/24/2023
• Device Model Number: G34110
• Device Catalogue Number: RMS-060024-R
• Device Lot Number: C1753434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/23/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 10/27/2020
• Supplement Dates FDA Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR