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

Model Number DIS150

Device Problem Material Twisted/Bent (2981)

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

Event Date 03/20/2023

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 on (b)(6) 2023 during an egd procedure and the guidewire bent.The procedure was completed without an alternate device.There was no impact or injury to the patient or user.This report is being raised due to the reported 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.We will continue to monitor for trends through the complaint system to assure patient safety.Device not yet received.

Manufacturer Narrative

Received one dis150 in unoriginal package.Lot number was not able to be verified.Performed a visual inspection, the complaint was confirmed.The guidewire was broken.A two-year lot history review shows a total of two devices for this lot number and failure mode.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.A two-year review of complaint history revealed there has been a total of 22 reports, regarding 27 devices, for this device family and failure mode.During this same time frame 104,717 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 0.0003.Per the instructions for use, the user is advised the following: 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.Additionally the ifu continues that the guidewire should not be advanced if resistance is met without determining the cause and taking remedial action.We will continue to monitor for trends 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 on 20mar23 during an egd procedure and the guidewire bent.The procedure was completed without an alternate device.There was no impact or injury to the patient or user.This report is being raised due to the reported 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: robin drum ; 11311 concept blvd.; largo, FL 33773 ; 8653881978
• MDR Report Key: 16955782
• MDR Text Key: 315856471
• Report Number: 3007305485-2023-00115
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 10653405986553
• UDI-Public: (01)10653405986553(17)240711(10)202207124
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 06/27/2023

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 Model Number: DIS150
• Device Catalogue Number: DIS150
• Device Lot Number: 202207124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/21/2023
• Initial Date FDA Received: 05/18/2023
• Supplement Dates Manufacturer Received: 06/27/2023
• Supplement Dates FDA Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic