MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE WHISPER LS GUIDE WIRE

Model Number	1005351H
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the circumflex artery.The whisper ls guide wire was advanced into the patient anatomy and crossed to the target lesion.An unspecified intravascular ultrasound (ivus) catheter was placed.During removal of the ivus catheter, resistance was noted; however, it was unknown if the resistance was between the ivus catheter and the patient anatomy, or with the ivus catheter and the guide wire.Force was applied to remove the ivus catheter and the guide wire separated.The ivus catheter and the guide wire were removed as a single unit and all segments of the separated guide wire were removed.There was no adverse patient effect.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported separation was confirmed.The reported difficulty to remove was not confirmed due to device condition.Additionally, the guidewire was noted to have a bent and kinked core and polymer coating, and torn material.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the intravascular ultrasound (ivus) catheter and guidewire resulted in the reported difficulty to remove.Manipulation of the device resulted in the noted bent core, polymer coating, kinked core, and torn material and ultimately resulted in the reported separation.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: HI-TORQUE WHISPER LS GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11038237
• Report Number: 2024168-2020-10697
• Device Sequence Number: 1047303
• Product Code: DQX
• UDI-Device Identifier: 08717648037740
• UDI-Public: 08717648037740
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2021

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 Expiration Date: 04/30/2022
• Device Model Number: 1005351H
• Device Catalogue Number: 1005351H
• Device Lot Number: 0050571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Received by Manufacturer: 11/27/2020
• Supplement Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 12/18/2020
• Supplement Report FDA Received Date: 01/09/2021
• 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: INTRAVASCULAR ULTRASOUND (IVUS)