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

Model Number	1001780-HC
Medical Device Problem Codes	Product Quality Problem (1506); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was performed to treat a mildly calcified lesion in an unknown vessel.During the use with the universal bmw ii guide wire an oct catheter could not pass over the guide wire due to an obstacle on the guide wire, and become stuck.The devices were removed as a single unit and the guide wire was replaced.A new guide wire was used with the same oct catheter successfully.There were no adverse patient effects nor clinical 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
Visual inspection and dimensional analysis were performed on the returned device.The reported obstacle was confirmed.The reported difficult to advance and difficult to remove were not confirmed due to the condition of the returned device with the contamination on the guide wire.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported difficulties appear to be related to circumstances of the procedure.Factors that may contribute to difficulty advancing and removing the guide wire include, but are not limited to challenging anatomy, device support, buildup of procedural contaminants, user technique, and/or damage to the guide wire which likely the result of the reported obstacle on the guide wire.In this case, it is likely that the reported obstacle on the guide wire contributed to the reported difficulties.It is likely that the blue loose contamination was caught on the guide wire from the user procedure gown during preparation during use, mishandling by the user, and/or possibly wiping the guide wire.Fourier transform infrared spectroscopy (ftir) testing was performed to identify the observed ball of fiber like material on the guide wire.Ftir testing result was concluded that the blue loose contamination was approximately 98% similarity to olefin.Based on the results of the complaint investigation, there is no indication a product quality issue with respect to manufacture, design or labeling of the device.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT¿
• 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: 22374071
• Report Number: 2024168-2025-06777
• Device Sequence Number: 7953053
• Product Code: DQX
• UDI-Device Identifier: 08717648025969
• UDI-Public: (01)08717648025969(11)241008(17)260930(10)4100872
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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): 12/09/2025

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: 09/30/2026
• Device Model Number: 1001780-HC
• Device Catalogue Number: 1001780-HC
• Device Lot Number: 4100872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2024
• 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