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

Model Number	1005359HJ
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to abbott vascular for analysis.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 incidents and/or complaints reported from this lot.There was no damage noted to the guide wire during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation determined the reported difficulty to remove and tip separation appear to be related to operational circumstances of the procedure.Based on the reported information, it is likely that manipulation during the procedure caused damage to the guide wire resulting in the reported difficulty to remove.Further manipulation against resistance during retraction resulted in the reported tip separation inside the guiding catheter.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the heavily calcified, mildly tortuous, 90% stenosed, left superior femoral artery (sfa).A 3cm 014 whisper guide wire (gw) was advanced into the guiding catheter (gc) without issue.During removal, the gw became stuck with the navicross gc and was unable to be advanced or pulled back.The catheter and guide wire were removed from the anatomy as one unit and it was noted that the tip of the guide wire had separated inside of the catheter.A command guide wire was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: HI-TORQUE WHISPER MS GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11784938
• Report Number: 2024168-2021-03859
• Device Sequence Number: 3610772
• Product Code: DQX
• UDI-Device Identifier: 08717648037832
• UDI-Public: 08717648037832
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K101116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/06/2021

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: 05/31/2022
• Device Model Number: 1005359HJ
• Device Catalogue Number: 1005359HJ
• Device Lot Number: 0060871
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR