MAUDE Adverse Event Report: CONMED CORPORATION .035 450CM STRAIGHT GUIDEWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number FX35450S

Device Problem Material Fragmentation (1261)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 04/30/2020

Event Type  Injury  

Manufacturer Narrative

The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

This distributor reported on behalf of their customer that the fx35450s was being used during a ercp on the (b)(6) 2020 when the "guidewire tip broke and remain a short segment in the gi tract." there was no report of injury to the patient and the procedure was reported to have been completed.Further assessment questions were sent to the reporter; however, the reporter declined to give further information.This report is being raised on the basis of injury due to known tip of device being left in patient.

Manufacturer Narrative

Correction: results were previously 3252 and is now 213.Conclusion was previously 4315 and is now 67.H10 was previously: evaluation: "received one fx3540s in opened original packaging.Lot number was verified.Performed a visual inspection of the device, the tip has a broken appears.All pieces were not returned." updated h10 below in manufacuturer narrative.Manufacturer narrative: received one fx3540s in opened original packaging.Lot number was verified.Performed a visual inspection of the device, the tip has a broken appearance.All pieces were not returned.During further investigation, the team decided to have the subject matter expert re-evaluate the unit to confirm initial evaluation findings and it was determined that the device was not broken.The device was conforming to specification.This issue will continue to be monitored through the complaint system to assure patient safety.

Manufacturer Narrative

Received one fx3540s in opened original packaging.Lot number was verified.Performed a visual inspection of the device, the tip has a broken appears.All pieces were not returned.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 1 complaints, regarding 1 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following: instructions for use: -inspect the guidewire for damage prior to use.Do not use if the wire has been bent, kinked, or damaged in any way.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: .035 450CM STRAIGHT GUIDEWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica, ny
• MDR Report Key: 10178396
• MDR Text Key: 195899724
• Report Number: 1320894-2020-00266
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• PMA/PMN Number: K050304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 09/04/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2022
• Device Catalogue Number: FX35450S
• Device Lot Number: 201905131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/22/2020
• Supplement Dates Manufacturer Received: 07/30/2020; 07/30/2020
• Supplement Dates FDA Received: 08/03/2020; 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other