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 Type  malfunction  

Manufacturer Narrative

The reported device has been returned to conmed; however, the evaluation of the device has not been completed.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

It was reported that the device, 000150, was being used during an unknown procedure on an unknown day in (b)(6) 2020 when the device was reported to have broken during surgery.The reusable spring tip guidewire was requested by the physician for the procedure.The savory wire was pulled from a package, it was not new.The surgical technician examined the guidewire and also tested the end for integrity, she grabbed the tip and gave it a tug, it did not break.It was then given to the physician.The physician also tested the guidewire and the wire/coil flexible end broke off prior to use in the patient.Upon further assessment, it was discovered the device broke during pre-operative testing.There was no report of injury, medical intervention, or hospitalization for the patient.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

Performed a visual inspection, the guidewire is broken.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.Performed a visual inspection, the tip of the wire is bent/kinked.A device history review cannot be conducted as no lot number was provided.A two-year lot history review cannot be conducted as no lot number was provided.(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: 11141263
• MDR Text Key: 225823272
• Report Number: 3007305485-2021-00014
• 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: 12/08/2020
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1