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

Catalog Number	1011834H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the 014whisper extra support guide wire separated during placement of a reentry catheter during an angioplasty.An attempt was made to snare the separated portion; however, was unsuccessful.The separated portion was retained in the patient within the sub intimal space post procedure.There was no adverse patient sequela and no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
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/complaints from this lot.The investigation determined the reported material separation, in addition to, the subsequent treatment and patient effect appear to be related to the operational context of the procedure.The separated portion of the guide wire was embedded within the anatomy.There is no indication of a product quality issue with respect to manufacture, design, or labeling.D9, h3: device returning updated from yes to no.E1: initial reporter update from non health professional to physician.G2: report source updated.

• Brand Name: HI-TORQUE WHISPER GUIDE WIRES
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 18346249
• Report Number: 2024168-2023-14144
• Device Sequence Number: 12317550
• Product Code: DQX
• UDI-Device Identifier: 08717648116100
• UDI-Public: 08717648116100
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 02/09/2024

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: 03/31/2025
• Device Catalogue Number: 1011834H
• Device Lot Number: 3040172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2023
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2023
• 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: OUTBACK CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male