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	07/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Voluntary medwatch form (mw5110881) received stating: when removing the wire, upon pulling back on the whisper wire, the distal wire tip broke.Fda safety report id# (b)(4).Additionally, the following information was received: it was reported that the procedure was to treat a heavily calcified, 95% stenosed lesion in the circumflex (cx) artery.When removing the 014 whisper guide wire from the anatomy, upon pulling back on the guide wire, the distal tip separated.A snare was used to remove the separated tip from the anatomy.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.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.The investigation was unable to determine a conclusive cause for the reported difficulties; however, the subsequent treatment appears to be related to the operational context of the procedure.Additionally, the reported removal of foreign body was due to a separated tip within the anatomy.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Medwatch report# mw5110881.

• 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
• 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: 15262985
• Report Number: 2024168-2022-08950
• Device Sequence Number: 5542341
• Product Code: DQX
• UDI-Device Identifier: 08717648037832
• UDI-Public: 08717648037832
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2022

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: 02/29/2024
• Device Model Number: 1005359HJ
• Device Catalogue Number: 1005359HJ
• Device Lot Number: 2031071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 08/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2022
• 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
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 92 KG