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

Model Number	1009666J
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2024
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.
Event or Problem Description
It was reported the bmw universal ii guide wire was advanced into the patient anatomy and an attempt was made to advance a non-abbott balloon catheter over the guide wire however resistance was noted therefore the balloon catheter was removed.A second bmw universal ii guide wire was used however the same non-abbott balloon catheter met resistance and became stuck on the guide wire.Both devices were removed as a single unit.The procedure was completed using a whisper guide wire.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device.The reported difficult to advance and remove could not be tested as it was based on operational context.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 and removal.Analysis of the returned wire confirmed the crossing profile was within specification.Functional analysis was performed, advancing the wire through a proxy catheter, with no resistance noted.The analysis also noted bends, corrosion, and stretched coils on the distal end.Corrosion is likely due to exposure during the return process.Bends and stretched coils are consistent with interaction during use.Damage to the wire¿s tip could impact a catheters maneuverability over the wire.It is likely that the wire sustained damage during use, resulting in the reported difficulty during advancement and removal.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported the bmw universal ii guide wire was advanced into the patient anatomy and an attempt was made to advance a non-abbott balloon catheter over the guide wire however resistance was noted therefore the balloon catheter was removed.A second bmw universal ii guide wire was used however the same non-abbott balloon catheter met resistance and became stuck on the guide wire.Both devices were removed as a single unit.The procedure was completed using a whisper guide wire.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Return device analysis of the second bmw universal ii guide wire noted corrosion on the proximal solder.

• 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: 20722598
• Report Number: 2024168-2024-13640
• Device Sequence Number: 3757775
• Product Code: DQX
• UDI-Device Identifier: 08717648118777
• UDI-Public: (01)08717648118777(17)250430(10)3052271
• 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,Followup
• Report Date (Section B): 03/03/2025

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: 04/30/2025
• Device Model Number: 1009666J
• Device Catalogue Number: 1009666J
• Device Lot Number: 3052271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2024
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2023
• 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: EUPHORA 2.5X15 BALLOON CATHETER
• Patient Sex: Unknown