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

Catalog Number 000150

Device Problem Material Fragmentation (1261)

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

Event Date 07/18/2018

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 the device, 000150, was being cleaned on b)(6) 2018 when the spring tip popped off the guidewire.There was no report of injury, medical intervention, or hospitalization for the patient.Due to the age of this complaint (date opened (b)(6) 2018), further assessment information could not be requested for this reassessment.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Inspection of the device found that the spring tip was missing.Inspection of the remaining device components was unable to determine the cause of the spring tip detaching.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 five years.A two-year review of complaint history revealed there has been a total of 24 complaints, regarding 24 devices, for this device family and failure mode.During this same time frame 56,622 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 0.0004.Per the instructions for use, the user is advised the following: since the marked guidewire is a reusable device that is subjected to varied use and cleaning environments, the life span of the product cannot be guaranteed.In particular, less than 1% of the spring tips have been reported to have become dislodged during reuse or cleaning.Dislodgement of the spring tip during use may require endoscopic removal of the spring tip.Failure to remove the tip may lead to the perforation of the esophagus, stomach or bowel and the consequences customarily associated therewith.Carefully inspect the guidewire after each use.Inspect the flexible spring tip and discard the wire if the tip appears to be bent or fatigued.Also inspect the soldered joint and discard the wire if the soldered joints appear discolored, loose or cracked.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: 11141281
• MDR Text Key: 241496636
• Report Number: 3007305485-2021-00016
• 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: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 02/01/2021

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1