MAUDE Adverse Event Report: ABBOTT VASCULAR INC. HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II; WIRE, GUIDE, CATHETER

Model Number	1009666J
Medical Device Problem Codes	Break (1069); Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device.The reported difficult to advance could not be tested due to the device condition.A review of the production records and the corrective and preventive actions (capa) database was performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.It was reported that the balloon catheter encountered resistance with the wire during advancement.Analysis of the returned wire confirmed the crossing profile was within specification.The analysis also noted bents on the distal end, a core break, and a separated tip.This type of damage is consistent with interaction during use.Damage to the wire¿s tip would impact a catheters maneuverability over the wire.It is likely that the wire sustained damage during use, resulting in the reported difficulty during advancement.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in an unknown vessel.A 190cm ht bmw guidewire was advance into the anatomy; however, resistance was noted at the weld point on the device when a balloon catheter was advanced over the wire.The guidewire was removed and replaced with a whisper guidewire and the procedure was completed.There was no reported adverse patient sequela and no clinically significant delay.Subsequent to the initially reported event, the device was received and the analyses revealed the distal solder tip was separated from distal end of coils.There was remnant of solder on the distal end of coils.The solder tip was not returned, and there was a break in the coils at 5cm (centimeters) proximally from distal end of guidewire.Confirmation of the additional damages were unable to be confirmed by the account.No additional information was provided.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II
• 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: 21598354
• Report Number: 2024168-2025-02628
• Device Sequence Number: 8938777
• Product Code: DQX
• UDI-Device Identifier: 08717648118777
• UDI-Public: (01)08717648118777(17)250630(10)3071471
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K152709
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/13/2025

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: 06/30/2025
• Device Model Number: 1009666J
• Device Catalogue Number: 1009666J
• Device Lot Number: 3071471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2023
• 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: BALLOON CATHETER
• Patient Age: 85 YR
• Patient Sex: Male