MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC SOEHENDRA STENT RETRIEVER; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	G21661
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.A follow-up emdr will be submitted within 30 days of submission of this report.
Event or Problem Description
During attempt of stent removal, the physician used a cook soehendra stent retriever.It was reported that an endoscope was inserted through the mouth, and a wire guide was inserted into the 8.5fr stent protruding from the papilla.After the wire guide was placed into the stent to be retrieved, the ercp cannula was removed and the ssr-8.5 was inserted into the stent over the wire guide.While turning the ssr-8.5 clockwise inside the stent, the threaded end came off.No particular resistance was felt when the screw came off.The removed threaded end was retrieved with forceps, and the procedure was completed without issue using an identical product (lot unknown) from the hospital's inventory.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
The investigation is ongoing.A follow-up emdr will be submitted within 30 days of receipt of new information.
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in a clear plastic bag.Provided with the return was an open pouch from the lot number provided in the report.The label matches the product returned.Our evaluation of the product said to be involved confirmed the report.A visual examination of the returned device shows the weld adhering the metal tip to the irrotational cable to not be intact.The metal tip has broken and was not provided with the return.A lab meeting was held with manufacturing engineering, capa engineering, and production leadership on (b)(6) 2025.During the lab meeting it was observed that expected rows of complete laser welds were at the incorrect location and incorrect number of rows.This is a process related nonconformance as the laser welder completes the welds using a preset program; however, correct weld placement is determined by component placement prior to welding and tooling position.The operator is not instructed to verify the number of welded rows or location of welds.Twenty-five (25) additional devices were pulled for visual inspection and tensile testing.It was noted that not all had the intended number of weld rows required, and not all weld rows positioned appropriately, but all were found to have adequate joint strength between the metal tip and cable during tensile testing.Thirty-six (36) additional devices were pulled from our shelf stock and submitted for torque testing and visual inspection.It was noted that not all had the intended number of weld rows required, and not all weld rows were positioned appropriately.Failures were observed within 2 of the acquired lots of ssr-11.5 devices for, torque, tensile, and manual tug testing.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: our laboratory evaluation confirmed the report based on the condition of the returned device.We were not able to complete a full devaluation as the metal tip was not included in the return.However, it was determined the likely cause of the failure was an inadequate weld connecting the metal tip to the cable.Manufacturing engineering, capa engineering, and production leadership, were notified of this occurrence.A corrective action (capa) was initiated to further investigate device failure due to ssr threaded tip weld deficiencies.The product said to be involved is included in the scope of the corrective action.A change order has been initiated to revise manufacturing instructions to improve clarity and detection for appearance and security of the laser weld between the irrotational cable and the threaded tip.Prior to distribution, all soehendra stent retrievers are subjected to a visual inspection and functional testing to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: a corrective action (capa) was initiated to further investigate device failure due to ssr threaded tip weld deficiencies.The product said to be involved is included in the scope of the corrective action.A review of the complaint history was conducted.There have been no other similar occurrences reported during the time period reviewed.Therefore, this report represents an isolated occurrence.Based on this review, the likelihood of this type of report is rare.Quality assurance will continue to monitor for complaint trends.

• Brand Name: SOEHENDRA STENT RETRIEVER
• Common Device Name: STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC
• Manufacturer (Section G): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston salem, NC 27105 ; 3367440157
• MDR Report Key: 23464936
• Report Number: 1037905-2025-00747
• Device Sequence Number: 10088923
• Product Code: FGE
• UDI-Device Identifier: 00827002216617
• UDI-Public: (01)00827002216617(17)280207(10)W4912176
• Combination Product (Y/N): N
• PMA/510(K) Number: K161203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G21661
• Device Catalogue Number: SSR-8.5
• Device Lot Number: W4912176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: 11/04/2025; 11/20/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 11/20/2025; 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS/JF-260V SCOPE.
• Patient Sex: Unknown