MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. RESOLVE CONVERTX® STENT SYSTEM.; NEPHROURETERAL.STENT SYSTEM

Catalog Number	RCX26-8-038/A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during a convertx drain-to-stent conversion, the stent would not completely detach from the external segment.(initial convertx placement (b)(6) 2022).It is alleged the clinician had proceeded to step 3 of the conversion process without incident.The clinician did not note any extra force needed or resistance when he pulled back on the release wire.The internal/external segments had appeared to be separated and the stent deployed.However, when he tried to withdraw the drain, the internal segment migrated along with drain.Two distinct segments of the release wire were visible, on both the internal and external components.An attempt to manipulate and withdraw the drain segment, was unsuccessful.The clinician planned to temporarily abandon the procedure and bring the patient in later that day.The merit rep immediately reached out to the product manager who in turn looped in the product management team and met with the clinician before the second procedure.Both the merit rep and product management team were available and conferenced into the procedure.The clinician carefully removed the hub of the catheter using a scalpel and exposed several cm's of both the release wire and internal loop suture.He then attempted several interventions, unsuccessfully, involving peel away flexor reinforced sheaths as well as advancing a kumpe catheter into the kidney wall, followed by employing an amplatz wire to create tension between the distal external segment and proximal/looped segment of the internal component.Next, he downsized to a 12f peel away and angled.038 amplatz, re-attempted and was successful.The release wire and internal loop suture were all withdrawn successfully.The distal segment of the release wire remained in the internalized segment post-procedure.It was noted by the clinican that it was a free-floating segment of wire.The clinican set the patient up for ct imaging and will decide if future intervention is warranted.No additional patient consequence to report.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The complaint is confirmed.No definitive root cause could be determined however, it is attributed to the manufacturing process.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: RESOLVE CONVERTX® STENT SYSTEM.
• Common Device Name: NEPHROURETERAL.STENT SYSTEM
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 14646 kirby drive; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 14646 kirby drive; houston TX 77047
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 13538918
• Report Number: 3010665433-2022-00014
• Device Sequence Number: 11876439
• Product Code: FAD
• UDI-Device Identifier: 00884450458587
• UDI-Public: 884450458587
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K161277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2022

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: 05/04/2023
• Device Catalogue Number: RCX26-8-038/A
• Device Lot Number: E2121727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2022
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 03/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Unknown