MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY 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 03/02/2022

Event Type  malfunction  

Manufacturer Narrative

The reported device is being returned to conmed for evaluation.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 device, 000150, marked guidewire (2/cs), was being used during an unknown procedure on (b)(6) 2022 when it was reported ¿spring tip guidewire was being used for wire guided dilation and tip broke of the wire while in use.Wire and tip were removed from scope and from inside the lumen of the dilator.¿.Another of the same type of device was used to complete the procedure with no report of delay.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Received one 000150 in unoriginal package.Lot number was not verified.Performed a visual inspection, the tip of the guidewire was damaged and broken.The broken part of the product was not returned.The manufacturing documents from the device history record have not been reviewed because the lot number of the device is not known.The lot history review was not conducted because the lot number of the device is not known.A two-year review of complaint history revealed there has been a total of 16 complaints, regarding 25 devices, for this device family and failure mode.During this same time frame 164,066 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.Per the instructions for use, the user is advised that the guidewire should not be advanced if resistance is met without determining the cause and taking remedial action.Carefully inspect the unit to verify that the sterile package of the product has not been damaged in shipment.Remove the guidewire from packaging and remove the tape attached to wire.Carefully inspect it for any damage that may have occurred during transit or handling.Carefully examine the guide wire 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 of the joints appears 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.

Event Description

The customer reported that the device, 000150, marked guidewire (2/cs), was being used during an unknown procedure on (b)(6) 2022 when it was reported ¿spring tip guidewire was being used for wire guided dilation and tip broke of the wire while in use.Wire and tip were removed from scope and from inside the lumen of the dilator.¿.Another of the same type of device was used to complete the procedure with no report of delay.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: MARKED GUIDEWIRE (2/CS)
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 13887878
• MDR Text Key: 289667947
• Report Number: 3007305485-2022-00035
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K853274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic