MAUDE Adverse Event Report: CONMED CORPORATION X-WIRE .025 IN. STD 450CM STRAIGHT TIP (3/CS); ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number 025450S

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

The reporter stated that the weight of the patient was 75; however, they did not advise if this was kilograms or pounds.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

The customer reported that the device, 025450s, was being used during an ercp procedure on (b)(6) 2020 when the hydrophilic coating tip started to peel off.A part of the coating became detached and was removed from the patient with a retrieval net.An alternate device, boston scientific jagwire, was used to complete the procedure.There was no report of delay to the procedure.There was no report of injury, medical intervention or hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Received one 025450s in opened original packaging.Lot number was verified.Performed a visual inspection, the tip of the x-wire is peeling.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 complaint, regarding 1 device, 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, (b)(4).Per the instructions for use, the user is advised the following: warnings: do no not attempt to withdraw the guidewire while the elevator is in the up position as this may damage the insulation to the guidewire.Use of a damaged guidewire may cause unsafe currents to either the patient or operator during electrosurgical cutting.Do not attempt to withdraw the wire through a metal needle, cannula or metal tipped catheter as this may damage the insulation to the guidewire.Use of a damaged guidewire may cause unsafe currents to either the patient or operator during electrosurgical cutting precautions: it is important that the instructions supplied with the electrosurgical unit be read, understood, and followed.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: X-WIRE .025 IN. STD 450CM STRAIGHT TIP (3/CS)
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 10740408
• MDR Text Key: 213200020
• Report Number: 1320894-2020-00460
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• PMA/PMN Number: K011759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2022
• Device Catalogue Number: 025450S
• Device Lot Number: 201912091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Initial Date Manufacturer Received: 10/05/2020
• Initial Date FDA Received: 10/27/2020
• Supplement Dates Manufacturer Received: 11/23/2020
• Supplement Dates FDA Received: 12/08/2020
• Patient Sequence Number: 1
• Treatment: BOSTON SCIENTIFIC JAGWIRE; BOSTON SCIENTIFIC JAGWIRE
• Patient Age: 46 YR