MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT MARKED GUIDEWIRE (2/CS); DILATOR, ESOPHAGEAL

Catalog Number 000150

Device Problem Material Twisted/Bent (2981)

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

Event Date 06/05/2020

Event Type  malfunction  

Manufacturer Narrative

At time of filing, the reported device was returned to conmed for evaluation.This reported event is reentering the investigation process.A supplemental and final report will be filed following the updated completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The customer reported that during an unknown procedure on (b)(6) 2020 the 000150, marked guidewire (2/cs), the device has a kink in it and can't be used.No injury to patient or user and no delay or cancellation was reported.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Customer event "has a kink in it and cannot be used" was confirmed based on photographic evidence and device evaluation.Received one 000150 in original packaging.Lot number was verified.Performed a visual inspection, the tip of the wire is bent/kinked.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 3 complaints, regarding 3 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: remove the guidewire from packaging and carefully inspect it for any damage that may have occurred during transit or handling.Carefully examine the guidewire and also test the tip of guidewire for integrity before each use to avoid detachment inside patients.If the tip of the guidewire exhibits wear, damage, abnormal bending or the joints appear discolored, loose or cracked, discard and do not use the device.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: MARKED GUIDEWIRE (2/CS)
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, 31136 ; MX 31136
• MDR Report Key: 11141283
• MDR Text Key: 242391905
• Report Number: 3007305485-2021-00015
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• PMA/PMN Number: K853274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 000150
• Device Lot Number: 201911274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1