MAUDE Adverse Event Report: ABBOTT VASCULAR INC. HI-TORQUE WHISPER; WIRE, GUIDE, CATHETER

Model Number	1005353H
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat an 100% stenosed lesion in the tibial artery with heavy calcification.The 014 whisper ls guide wire (gw) was advanced to the target lesion using a support catheter.Strong resistance was met during advancement due to the heavy calcification and 8cm of the gw became separated at the distal end.The proximal end of the gw was removed and difficulty was also noted due to the anatomy.There was no attempt to retrieve the separated distal portion because it was stuck in a collateral artery.There was no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device.The reported core separation was confirmed.The reported difficult to advance and difficult to remove could not be tested due to the device condition.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/complaints from this lot.The investigation determined the reported difficulties and foreign body in patient appear to be related to the operational context of the procedure.Additionally, there was no attempt to retrieve the separated portion of the guide wire.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Additional Manufacturer Narrative
H2: updated the device identification fields to align with the information in the corresponding fields in gudid.

• Brand Name: HI-TORQUE WHISPER
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005737652; road no.2 km 58.0 cruce dávila; barceloneta PR 00617
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18030848
• Report Number: 2024168-2023-11965
• Device Sequence Number: 12517005
• Product Code: DQX
• UDI-Device Identifier: 08717648037764
• UDI-Public: (01)08717648037764(17)240331(10)2041271
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2024

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: 03/31/2024
• Device Model Number: 1005353H
• Device Catalogue Number: 1005353H
• Device Lot Number: 2041271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/06/2023
• Supplement Date Received by Manufacturer: 01/02/2024; 06/13/2024
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 01/12/2024; 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BERENSTEIN CATHETER.; RUBICON CATHETER.; TRAILBLAZER SUPPORT CATHETER.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown