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

Catalog Number DIS150

Device Problem Fracture (1260)

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

Event Date 11/07/2023

Event Type  malfunction  

Event Description

The sales representative reported on behalf of the customer that the dis150, disposable marked spring tip guidewire, was being tested prior to a procedure on (b)(6) 2023 when it was reported, ¿guidewire broke.".There was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed with an alternate same device causing a 2-minute delay in the procedure.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.

Manufacturer Narrative

Correction to evaluation: the device will not be returned for evaluation, but photographic evidence has been provided.Root cause cannot be determined, however, based on the provided photo; a possible cause of this event could be excessive force.The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction 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.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.Guidewire is inserted through the biopsy channel of an endoscope with the spring tip to be located just past the esophagogastric (e.G.) junction into the gastric cavity.The endoscope is then withdrawn.The guidewire should be monitored externally using markings as dental arch reference points before and during dilatation.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 tested prior to a procedure on (b)(6) 2023 when it was reported, ¿guidewire broke." there was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed with an alternate same device causing a 2-minute delay in the procedure.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, a device malfunction 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.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.Guidewire is inserted through the biopsy channel of an endoscope with the spring tip to be located just past the esophogastric (e.G.) junction into the gastric cavity.The endoscope is then withdrawn.The guidewire should be monitored externally using markings as dental arch reference points before and during dilatation.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 tested prior to a procedure on (b)(6) 2023 when it was reported, ¿guidewire broke." there was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed with an alternate same device causing a 2-minute delay in the procedure.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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 18245174
• MDR Text Key: 329458004
• Report Number: 3007305485-2023-00244
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 10653405986553
• UDI-Public: (01)10653405986553(17)250417(10)202304185
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• 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: 202304185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic