MAUDE Adverse Event Report: CONMED CORPORATION MARKED SPRING TIP GUIDEWIRE

Catalog Number 000150

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported, "3 spring tip guide wires broke.Only have 2/3 to send in for inspection.Were all used in separate procedures." (b)(4) 2014 - on receipt of the devices, it was noted that one of the devices was not broken; however, the spring tip of the device was bent making this reportable due to a past sentinel event.Our date of awareness for event reportability has now changed to (b)(6) 2014.It was also reported that there was no patient injury.

Manufacturer Narrative

This is an fda reportable event due to a sentinel event reported on medwatch 3007305485-2011-00067.This complaint was originally evaluated as a non-reportable event.Upon receipt of the device on (b)(4) 2014, the condition in which the device was returned (spring tip of guidewire is bent).The evaluation of reportability status changed due to a past sentinel event involving a bent spring tip of this device.The evaluation is anticipated; however , has not commenced to date.On completion of the quality engineering investigation a supplemental report will be filed.

Manufacturer Narrative

The device in question is the marked spring tip guidewire, a 210cm long solid metal mandrel with a flexible, variable thread, spring attached to the proximal tip.The marked spring tip guidewire is a reusable instrument to be used in conjunction with american dilators and is compatible with key med, savary, eder puestow, and celestin esophageal dilator systems.A dhr/lhr, device history record/lot history record, review was not accomplished for the lot number was not available.One (1) used marked spring tip guidewire (accessory for american dilator system), non sterile, cat# 000150 was returned with no factory packaging as an actual sample against a customer complaint.The device was examined in the laboratory.Visual inspection found the device in poor condition in that the spring tip guidewire was bent at the proximal end of the distal tip.This device does not function as designed and intended.The laboratory was able to reproduce and/or verify the reported failure mode thus, this complaint is confirmed.It is highly unlikely that products were shipped to the customer in the current condition.In-process and quality control inspection are done on the product and this failure mode is highly detectable.100% of the devices undergo hand pull and proof load guidewire to spring tests to assure proper function.Furthermore, damaged devices are scrapped during production.Improper handling of the device after shipping from conmed facility to the end-user facility could cause this complaint.The proximal end of the spring is less flexible than the distal end of the spring thus, excess force applied on the device during guidewire insertion/retraction process could cause tip to bend.The ifu, instructions for use, indicates, "the guidewire should not be advanced if resistance is met without determining the cause and taking remedial action." the ifu also specifies, "remove the guidewire from packaging and carefully inspect it for any damage that may have occurred during transit or handling." thus, a damaged device should be detectable prior to any patient use.The ifu also specifies, "avoid using excessive force on the wire and spring tip while cleaning.Do not bend to twist the spring tip as it may cause the soldered joints to deteriorate." possible cause for this complaint could be device damage post production, during device cleaning, or, excessive force used by the end-user on insertion/retraction of the device from the endoscope.No manufacturing related defect was observed during the investigation; therefore, no corrective action is recommended at this time.Conmed corporation is considering this complaint closed.

• Brand Name: MARKED SPRING TIP GUIDEWIRE
• Type of Device: MARKED SPRING TIP GUIDEWIRE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 599
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas no. 11321; complejo industrial chihuahua; chihuahua, chihuahua CP 1 136; MX CP 1136
• Manufacturer Contact: stephen casanova ; 525 french road; utica, NY 13502-5994 ; 3156243463
• MDR Report Key: 3594538
• MDR Text Key: 4186231
• Report Number: 3007305485-2014-00010
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/26/2014

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
• Device Operator: Health Professional
• Device Catalogue Number: 000150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/20/2013
• Initial Date FDA Received: 01/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1