MAUDE Adverse Event Report: CONMED CORPORATION MARKED GUIDEWIRE; AMERICAN DILATION SYSTEM

Model Number	000150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The used device was returned to conmed with original opened product packaging.Upon visual inspection, the device's spring tip was observed to be detached from the rest of the device from the distal tip of the device.Within proximity to the fracture point, it was observed that the detached spring tip component was bent.Due to the bend observed within proximity to the fracture point of the device's spring tip component, it is possible that an applied force is related to the cause of this defect.A review of the manufacturing documents verified the device was produced per current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified at the time of manufacture.A review of this lot number, with (b)(4) devices manufactured, showed no other complaint for this lot product and event description.A two-year review of complaint history revealed 5 other similar complaints for this product family and failure mode.In that same timeframe, (b)(4) of this product family have been sold worldwide, making the rate of occurrence of this confirmed failure (b)(4) percent, if all complaints were confirmed.The instructions for use advises the user of the following.The guidewire should not be advanced if resistance is met without determining the cause and taking remedial action.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 of the soldered joints appear discolored, lose or cracked.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The user facility reported that during a procedure, the 000150 guidewire spring tip broke off inside the patient.The broken piece was retrieved with a snare and the procedure was completed with an alternate guidewire.The patient did not require additional treatment due to this incident and no injury was reported.This report is raised on the basis of a reported malfunction that may have contributed to an injury.

• Brand Name: MARKED GUIDEWIRE
• Common Device Name: AMERICAN DILATION SYSTEM
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• MDR Report Key: 7363775
• Report Number: 3007305485-2018-00066
• Device Sequence Number: 10806428
• Product Code: KNQ
• UDI-Device Identifier: 30653405050852
• UDI-Public: (01)30653405050852(11)170912(10)201709124
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/22/2018

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: Health Professional
• Device Model Number: 000150
• Device Catalogue Number: 000150
• Device Lot Number: 201709124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 03/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Weight: 73