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

Model Number	1005357H
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The additional ht whisper guide wire device referenced is filed under a separate medwatch report number.Na.
Event or Problem Description
It was reported that the procedure was to treat the left anterior descending artery and right coronary artery.Two whisper ms guide wires were used in the procedure and it was confirmed that no fluff/fabric was noted on the guide wires prior to entering the anatomy as it was prepped and inspected per the instructions for use.It was confirmed that the guide wires were not removed at any point during the procedure to be wiped down.However, once removed out of the anatomy as the procedure was completed, fabric/fluff looking material was noted on both guide wires.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported contamination was confirmed.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 one other similar incident reported from this lot.However, this is not a lot specific product quality issue.The investigation determined that operational context is the likely cause of the reported difficulties.The device was sent to fourier transform infrared spectroscopy (ftir) for further analysis of the contamination.Ftir conclusion found that the loose fiber wrapped around the proximal core was cellulose or plant based (cotton ball or kimwipe fibers).It is likely that the fibers found on the device occurred with a cleaning wipe or similar material used during the procedure.The noted bends are likely due to procedural circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 11166124
• Report Number: 2024168-2021-00410
• Device Sequence Number: 3717573
• Product Code: DQX
• UDI-Device Identifier: 08717648037801
• UDI-Public: 08717648037801
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2021

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: 08/31/2021
• Device Model Number: 1005357H
• Device Catalogue Number: 1005357H
• Device Lot Number: 9092571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Initial Date Received by Manufacturer: 12/31/2020
• Supplement Date Received by Manufacturer: 04/02/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 04/13/2021
• 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: WHISPER MS GW