MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY DISPOSABLE MARKED SPRING TIP GUIDEWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number DIS150

Device Problem Material Fragmentation (1261)

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

Event Date 01/20/2022

Event Type  malfunction  

Event Description

The sales representative reported on behalf of the customer that the dis150, disposable marked spring tip guidewire, was being used during a standard wire-guided salivary dilation procedure on (b)(6) 2022 when it was reported, ¿spring tip guidewire that the wire broke yesterday while in the patient.No harm was done to the patient.¿ there was no report of injury, medical intervention, or hospitalization for the patient.Further assessment questioning of the sales representative found that the component was retrieved from the patient using a snare.The procedure was completed successfully after a 10-minute delay.The current status of the patient was listed as ¿healthy¿.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

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.

Manufacturer Narrative

Received one dis150 in opened original packaging.Lot number was verified.Performed a visual inspection, the complaint has been confirmed.The wire is broke.The broken piece of the wire was not returned with the device.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 15 complaints, regarding 24 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.(b)(4).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.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the dis150, disposable marked spring tip guidewire, was being used during a standard wire-guided salivary dilation procedure on (b)(6) 2022 when it was reported, ¿spring tip guidewire that the wire broke yesterday while in the patient.No harm was done to the patient.¿ there was no report of injury, medical intervention, or hospitalization for the patient.Further assessment questioning of the sales representative found that the component was retrieved from the patient using a snare.The procedure was completed successfully after a 10-minute delay.The current status of the patient was listed as ¿healthy¿.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: DISPOSABLE MARKED SPRING TIP GUIDEWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• 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: 13497015
• MDR Text Key: 288487274
• Report Number: 3007305485-2022-00013
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2023
• Device Catalogue Number: DIS150
• Device Lot Number: 202101254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Initial Date Manufacturer Received: 01/20/2022
• Initial Date FDA Received: 02/09/2022
• Supplement Dates Manufacturer Received: 02/23/2022
• Supplement Dates FDA Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic