MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

Catalog Number	1009664J
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.Na.
Event or Problem Description
It was reported that when attempting to remove the ht bmw universal guidewire from the packaging, it was noted to be stuck to the dispenser coil.The guidewire was removed with force and became very stretched.It could not be confirmed if the guidewire was intact when pulled out of the packaging [unraveled].The device was not used in the patient and the procedure was completed with another bmw guidewire.There was no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported core break and stretched coils were confirmed.The reported difficult to remove could not be tested due to the device condition.A review of production records 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 similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.In this case, it was reported that the guide wire experienced resistance during removal from the dispenser hoop, resulting in stretched coils and a core break.Analysis of the returned device confirmed that the coils were stretched distally, and the shaping ribbon separated from the core.This type of damage aligns with the guide wire being pulled against resistance.A proxy guide wire was advanced and removed through the dispenser hoop with no resistance was noted.Based on the return analysis, it is unknown what may have contributed to the reported issue.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 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: 18749372
• Report Number: 2024168-2024-02155
• Device Sequence Number: 15020649
• Product Code: DQX
• UDI-Device Identifier: 08717648118753
• UDI-Public: (01)08717648118753(17)250731(10)3081571
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K072460
• 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): 05/17/2024

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: 07/31/2025
• Device Catalogue Number: 1009664J
• Device Lot Number: 3081571
• 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: 02/01/2024
• Supplement Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2023
• 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
• Patient Sex: Unknown