MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT MARKED GUIDEWIRE; AMERICAN DILATION SYSTEM

Model Number 000150

Device Problem Bent (1059)

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

Event Date 09/25/2017

Event Type  malfunction  

Manufacturer Narrative

The used device was returned for evaluation without original product packaging.Ref and lot numbers were not verified for this product.Visual inspection found the device was damaged at the joint between the spring tip and guidewire.It was also noted that the spring had partially unwound near the distal end of the spring, which may indicate excess tensile force applied to the spring.Potential causes of the damage may be deterioration of the spring tip joint caused by overuse of the device, as well as excessive force during cleaning, handling, and use of the device.A review of the manufacturing documents has verified the devices were produced per current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture that would contribute to this issue.Risk assessment found this issue to be consistent with current risk documents.Due to breakage and detachment of the guidewire spring tip a process verification was performed and no issues were found.This failure mode is mitigated during manufacturing by a 100% pull force test of the joint between the spring and guidewire.(b)(4).The instructions for use advise the user of the following.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 1% 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." 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.Inspect the soldered joints and discard the wire if the soldered joints appear discolored, loose or cracked.Avoid using excessive force on the wire and spring top while cleaning.Do not bend or twist the spring tip as it may cause the soldered joints to deteriorate.Since the marked guidewire is a reusable device that is subject to varied use and cleaning environments, the life span of the product cannot be guaranteed.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The conmed sales representative reported on behalf of the user facility that at the end of an egd procedure, the marked guidewire was observed to be bent.The procedure was completed with no reported surgical delays or patient injury.This report is raised on the basis of a reported malfunction with potential for injury with recurrence.

• Brand Name: MARKED GUIDEWIRE
• Type of Device: AMERICAN DILATION SYSTEM
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; ave. alejandro dumas no. 11321; complejo industrial chihuahua; chihuahua, chihuahua CP 31 136; MX CP 31136
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer Contact: martha camacho urribarri ; 525 french road; utica, NY 13502-5994
• MDR Report Key: 6964872
• MDR Text Key: 90667342
• Report Number: 3007305485-2017-00230
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 30653405050852
• UDI-Public: (01)30653405050852(11)161130(10)201611304
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 000150
• Device Catalogue Number: 000150
• Device Lot Number: 201611304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1