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, " as soon as the devices went through the scope, you could see that they bent.(2 separate devices and occurrences) " 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 3007305485-2013-00025.The evaluation is anticipated; however, has not commenced to date.On completion of the quality engineering investigation a supplemental report will be filed.This medwatch is associated with medwatch 3007305485-2014-00039, filed for the second device.

Manufacturer Narrative

This medwatch was submitted today with incorrect data.The date received by manufacturer is actually 03/26/2014.

• 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: 3757258
• MDR Text Key: 4555128
• Report Number: 3007305485-2014-00038
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/17/2014

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: 04/04/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/26/2014
• Initial Date FDA Received: 04/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/17/2014
• Was Device Evaluated by Manufacturer?: No
• 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