MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY MARKED GUIDEWIRE (2/CS); DILATOR, ESOPHAGEAL

Catalog Number 000150

Device Problem Material Fragmentation (1261)

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

Event Date 05/09/2023

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.A two-year lot history review cannot be conducted as a lot number was not provided.A device history record review cannot be conducted as a lot number was not provided.A two-year review of complaint history revealed there has been a total of 21 reports, regarding 21 devices, for this device family and failure mode.During this same time frame (b)(4) 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: the guidewire should not be advanced if resistance is met without determining the cause and taking remedial action.Since the marked guidewire is a reusable device that is subjected to varied use and cleaning environments, the life span of the product cannot be guaranteed.In particular, less than % of the spring tips have been reported to have become dislodged during reuse or cleaning.Dislodgement of the spring tip during use may require endoscopic removal of the spring tip.Failure to remove the tip may lead to the perforation of the esophagus, stomach or bowel and the consequences customarily associated therewith.Before and after each use, carefully inspect the guidewire for wear, damage or abnormal bending.The entire wire should be inspected in this manner, but areas of extra focus include the flexible spring tip and the soldered joints between the spring tip and the wire.If the joints appear discolored, loose or cracked, discard the guidewire.If wear, damage, or abnormal bending is found at any location on the guidewire, discard the guidewire.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 000150 marked guidewire was being used on (b)(6) 2023 during a dilation procedure and the ¿tip of guidewire broke off during dilation¿ the procedure was completed with a new wire.There was no injury or impact to the patient or user.After further assessment it was found that the "wire was taken out of the packaging and hld (high level disinfectant) prior to initial use.She had told me previously she didn¿t have the lot/serial number because they had taken it out of the package and put it through high level disinfectant prior to use, so didn¿t have the packaging at the time of the procedure.While removing the wire after dilation, the tip came off at the tip of the mouth." there was no medical or surgical intervention or prolonged hospitalization required for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: MARKED GUIDEWIRE (2/CS)
• Type of Device: DILATOR, ESOPHAGEAL
• 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: 17032498
• MDR Text Key: 316259402
• Report Number: 3007305485-2023-00127
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K853274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 000150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic