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 03/26/2021

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

The customer reported that the 000150 device was being used during an unknown procedure on (b)(6) 2021 and the device "broke off in patients stomach.Retrieved.No patient impact." upon further assessment, it was discovered a snare was used to retrieve the wire.There was no injury to the patient or user reported.There was also no report of medical intervention or hospitalization for this event.There was maybe a 30 minute delay.The procedure was reported to have been completed successfully.

Manufacturer Narrative

Received one 000150 in opened original packaging.Lot number was verified.Performed a visual inspection, the guidewire has a clean break at the spring.All pieces were returned.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 8 complaints, regarding 17 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: the guidewire should be not advanced if resistance is met without determining the cause and taking remedial action.Before and after each use, carefully inspect the guidewire for wear, damage or abnormal bending.The entire wire should be inspected in this manner, but areas of extra focus include the flexible spring tip and the soldered joints between the spring tip and the wire.If the joints appear discolored, loose or cracked, discard the guidewire.If wear, damage or abnormal bending is found at any location on the guidewire discard the guidewire.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: 11671112
• MDR Text Key: 280539078
• Report Number: 3007305485-2021-00195
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• 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: 202102024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2021
• Date Manufacturer Received: 05/12/2021
• Patient Sequence Number: 1