MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE WHISPER MS GUIDE WIRE; GUIDE WIRES

Catalog Number	1005359H
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	09/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was returned for analysis.The reported detachment was able to be confirmed.The reported physical resistance and the reported difficulty to position were unable to be replicated in a testing environment as they were based on operational circumstances.A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that as the device was advanced, resistance was met with the heavily calcified, 99% occluded anatomy and the 2.0 x 20 mm mini trek balloon dilatation catheter resulting in the reported physical resistance and the reported difficulty to position.Manipulation of the device resulted in the noted separated polymer coating and the reported/noted core and coil detachments.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported this was a limb salvage case.The procedure was performed to treat a 99% occluded lesion in the anterior tibial artery with heavy calcification.The whisper guide wire and 2.0 x 20 mm mini trek otw balloon dilatation catheter (bdc) were advanced to the lesion.The whisper guide wire was attempted to be advanced further, but resistance was felt with the mini trek bdc and the calcification, and the tip of the guide wire broke in the vessel.The mini trek and whisper were removed without issue.An un-specified guide wire and bdc were then advanced successfully.The separated tip of the whisper guide wire was crushed against the vessel wall, and the target lesion was successfully dilated.The patient had good flow and the procedure was completed.No additional information was provided.

• Brand Name: HI-TORQUE WHISPER MS GUIDE WIRE
• Common Device Name: GUIDE WIRES
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6979884
• Report Number: 2024168-2017-08490
• Device Sequence Number: 19168754
• Product Code: DQX
• UDI-Device Identifier: 08717648037825
• UDI-Public: 08717648037825
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K101116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1005359H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2017
• Initial Report FDA Received Date: 10/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DILATATION CATHETER: MINI TREK OTW BDC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR