MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT MARKED GUIDEWIRE; DILATOR, ESOPHAGEAL

Catalog Number 000150

Device Problem Material Twisted/Bent (2981)

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

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 facility, (b)(6) center reported issues with the 000150, marked guidewire, lot 201611144.Information received indicates that the facility received the item out of packaging and noticed bends in the wire.The device was never used on a patient or in a surgical procedure because the issue was noticed immediately upon receipt.There is no allegation of patient harm, however, this report is now being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The customer's reported complaint of a bent device is confirmed.The reported device was returned to conmed and evaluated.A visual inspection performed observed slight bends in wire and spring components, however a root cause can not be identified.The manufacturing documents from the device history record have been reviewed and found no abnormalities that would contribute to this issue.A five-year lot history review shows this is the only complaint for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of (b)(4)complaints, regarding 47 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 0.0002.The instructions for use (ifu) provides the user with information regarding proper care and use of this device.The ifu also states, "warning: 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." also, "warning: 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 joints and discard the wire if the soldered joints appear discolored, loose or cracked." the recommended proper cleaning instructions are presented in the ifu.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: MARKED GUIDEWIRE
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, mexico 31136 ; MX 31136
• MDR Report Key: 11139138
• MDR Text Key: 246651889
• Report Number: 3007305485-2021-00007
• 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: 02/11/2021

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: No Information
• Device Catalogue Number: 000150
• Device Lot Number: 201611144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2016
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1