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

Model Number	000150
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received one 000150 in unoriginal packaging.Lot number could not be verified.Performed a visual inspection of the device and found that the marked spring tip on the guidewire is bent.This is a technique-dependent device and the most likely cause of this suspected failure is user-related.No functional failure or defect could be identified.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 7 complaints, regarding 7 devices, for this device family and failure mode.During this same time frame 25,034 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: warnings: the guidewire should not be advanced if resistance is met without determining the cause and taking remedial action.Carefully inspect the 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 or Problem Description
The sales representative reported on behalf of the customer that the, 000150, device bent during a dilation with savary dilators procedure on (b)(6) 2019.The facility reported, "while in use, guidewire bent at the end and could have potentially perforated the patient's esophagus." there was no report of patient or user injury, no medical intervention required and no hospitalization.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: MARKED GUIDEWIRE
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, 31136 ; MX 31136
• MDR Report Key: 8653486
• Report Number: 3007305485-2019-00186
• Device Sequence Number: 11428592
• Product Code: KNQ
• UDI-Device Identifier: 30653405050852
• UDI-Public: (01)30653405050852(11)171130(10)201711304
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K853274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/30/2019

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
• Operator of Device: No Information
• Device Model Number: 000150
• Device Catalogue Number: 000150
• Device Lot Number: 201711304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 05/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1