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

Model Number	1005357H
Medical Device Problem Codes	Off-Label Use (1494); Difficult to Remove (1528); Material Separation (1562); Failure to Advance (2524)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.Na.
Event or Problem Description
It was reported that during a pacemaker procedure resistance was felt with the anatomy during advancement of the whisper guide wire, the guide wire did not cross through the superior vena cava.Resistance was also felt as the guide wire was pulled back.The tip of the guide wire separated, and a snare device was used in an attempt to retrieve the guide wire tip; however, the tip was unable to be retrieved.The tip remains in the anatomy.An unspecified guide wire was used to continue the procedure.There was no adverse patient sequela and no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned 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 from this lot.Reportedly, the device was used during a pacemaker procedure.It should be noted that the hi-torque guide wires instructions for use (ifu) / intended for use states: all hi-torque guide wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (ptca) and percutaneous transluminal angioplasty (pta).The deviation of the ifu does not appear to have caused/contributed to the reported difficulties.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during advancement resistance was met with the anatomy resulting in the reported failure to advance and the reported difficult to remove.Manipulation of the device ultimately resulted in the reported material separation.The treatment appears to be related to the operational context of the procedure as a snare device was used in an attempt to retrieve the guide wire tip; however, the tip was unable to be retrieved.The tip remains in the anatomy.There is no indication of a product quality issue with respect to manufacture, design or labeling.D9, h3: device was not available for evaluation.

• 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: 12037908
• Report Number: 2024168-2021-05244
• Device Sequence Number: 11827165
• Product Code: DQX
• UDI-Device Identifier: 08717648037801
• UDI-Public: 08717648037801
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 07/13/2021

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 Expiration Date: 02/28/2023
• Device Model Number: 1005357H
• Device Catalogue Number: 1005357H
• Device Lot Number: 1030871
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 07/13/2021
• 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: Required Intervention
• Patient Age: 89 YR