MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT MARKED GUIDEWIRE; DILATOR, ESOPHAGEAL

Catalog Number 000150

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/23/2020

Event Type  malfunction  

Manufacturer Narrative

The alleged broken 000150 is not expected to be returned for evaluation and review.This complaint of broken device is unable to be verified and a root cause cannot be determined.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.A two-year review of complaint history revealed there has been a total of one complaint, regarding one device, for this device family and failure mode.During this same time frame 75,658 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 0.00001.Per the instructions for use, the user is advised the following: warnings: -this 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 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 perforation of the esophagus, stomach or bowel and the consequences customarily associated therewith.-carefully inspect the reusable guidewire after each use.Inspect the flexible spring tip and discard the wire if the tip appears to be bent or fatigued.Also inspect the soldered joints and discard the wire if the soldered joints appear discolored, loose or cracked.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

This complaint was created due to the receipt of a medwatch report (mw5092972) received from the fda on (b)(6) 2020.A search of the complaint system has not found a complaint reported for this device during this timeframe.The 000150, marked guidewire, device was reported as being used during an egd procedure on (b)(6) 2020 when the reusable guidewire spring tip broke off inside the patient.The physician removed the guidewire from the scope and proceeded to insert a snare to retrieve the wire spring.The components were removed from the patient.The procedure was successfully completed with no reported delay.The patient is reported as having not sustained any injury and denied any problems during the follow up call the following business day.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: MARKED GUIDEWIRE
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, 31136 ; MX 31136
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, 31136 ; MX 31136
• Manufacturer Contact: john berga ; 11311 concept blvd.; largo, fl ; 3995358
• MDR Report Key: 9883743
• MDR Text Key: 196952633
• Report Number: 3007305485-2020-00126
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 00653405050851
• UDI-Public: (01)00653405050851(30)1(10)0906254
• 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,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• 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: 0906254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2009
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 93