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

Model Number DIS150

Device Problem Fracture (1260)

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

Event Date 04/17/2023

Event Type  malfunction  

Event Description

This complaint was created due to the receipt of a medwatch report (2300380000-2023-8017) on (b)(6)2023.The current complaint database has been researched for this event and there were no findings.The report was found to be written against device, dis150, disposable marked spring tip guidewire.It was stated that the device was being used during an endoscopy procedure that occurred on (b)(6)2023.The report stated, ¿we have had multiple incidents where conmed disposable guide wires have snapped partially through.This issue has involved at least 2 different lot numbers that we are aware of.¿.There was no report of injury, medical intervention, or hospitalization for the patient.There was no report of fragmentation.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

This complaint was created due to the receipt of a medwatch report (b)(4) on 9may2023.The current complaint database has been researched for this event and there were no findings.The report was found to be written against device, dis150, disposable marked spring tip guidewire.It was stated that the device was being used during an endoscopy procedure that occurred on (b)(6) 2023.The report stated, "we have had multiple incidents where conmed disposable guide wires have snapped partially through.This issue has involved at least 2 different lot numbers that we are aware of." there was no report of injury, medical intervention, or hospitalization for the patient.There was no report of fragmentation.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device will not be returned, and no photographic evidence was provided.Therefore, the reported event cannot be verified.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: 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.

• 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: 17009080
• MDR Text Key: 316003402
• Report Number: 3007305485-2023-00125
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 10653405986553
• UDI-Public: (01)10653405986553(17)240728(10)202207294
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• 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: 202207294
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic