MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT DISPOSABLE MARKED SPRING TIP GUIDEWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number DIS150

Device Problem Material Deformation (2976)

Patient Problem Abrasion (1689)

Event Date 08/21/2020

Event Type  malfunction  

Manufacturer Narrative

At time of filing, although expected, the reported device has not been 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

On behalf of the facility, the conmed representative reported issues with the dis150, disposable marked spring tip guidewire, lot 202005044, (b)(6).Recently experienced on (b)(6) 2020.Information received was that the physician pulled dilator out and the guidewire looked abnormal.After going back in with the scope it appeared that the patient's stomach was scratched.It is noted the procedure was successfully completed (without using alternate device) and the "outcome of the procedure was not stated to be affected by this".The only additional information received noted the procedure was egd with savory dilation and after the dilation guidewire was removed with kink in end, scratching on mucosa in stomach was noted.No other treatment necessary.Single use device.The patient's condition is unchanged and nothing was noted prior to using guidewire.There is no indication of bleeding, no additional medical intervention was needed and the patients condition was not impacted by the incident.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Received one dis150 in opened original packaging.Lot number was verified.Performed a visual inspection, the guidewire is bent and damaged toward the distal end of the device.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.(b)(4).Per the instructions for use, the user is advised the following: warnings: the guidewire should not be advanced if resistance is met without determining the cause and taking remedial action.Instructions for use: carefully inspect the unit to verify that the sterile package of the product has not been damaged in shipment.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: DISPOSABLE MARKED SPRING TIP GUIDEWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, 31136 ; MX 31136
• MDR Report Key: 10620413
• MDR Text Key: 222533204
• Report Number: 3007305485-2020-00415
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2021
• Device Catalogue Number: DIS150
• Device Lot Number: 202005044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Date Manufacturer Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1