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

Catalog Number DIS150

Device Problem Material Twisted/Bent (2981)

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

Event Date 07/06/2023

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.We will continue to monitor for trends through the complaint system to assure patient safety.H3 other text : device not yet received.

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 ¿savory wire was bent during use during an egd.This has been occurring multiple times during procedures.No physical injury occurred to patient.Defective wire sent to departments emi person.".There was no impact or injury to the patient.The procedure was completed without an alternate device.Further assessment was sent; however, the reporter responded they did not have any more information regarding this incident.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device has not been returned to date and no photographic evidence was provided.Therefore, the reported event cannot be verified.If the device is returned, at a later date, the investigation may be updated and reanalyzed.[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.(b)(4).Per the instructions for use, the user is advised the following: 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 (b)(6) 2023 during an egd procedure and the ¿savory wire was bent during use during an egd.This has been occurring multiple times during procedures.No physical injury occurred to patient.Defective wire sent to departments emi person.".There was no impact or injury to the patient.The procedure was completed without an alternate device.Further assessment was sent; however, the reporter responded they did not have any more information regarding this incident.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: 17397358
• MDR Text Key: 319795064
• Report Number: 3007305485-2023-00177
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 10653405986553
• UDI-Public: (01)10653405986553(17)240811(10)202208124
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/13/2023

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 Catalogue Number: DIS150
• Device Lot Number: 202208124
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 07/26/2023
• Supplement Dates Manufacturer Received: 09/06/2023
• Supplement Dates FDA Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic