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

Model Number	1009660
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	03/18/2025
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.The additional device referenced in b5 is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat the left anterior descending (lad) coronary artery with moderate calcification and mild tortuosity.A balance middleweight guide wire was in place in the lad and during withdrawal of the 4x20 mm nc trek neo balloon dilatation catheter (bdc) along the guide wire, there was resistance.Upon simple removal without force from the anatomy it was noted a piece of the bmw guide wire had torn off.No material was left in the patient.There were no adverse patient effects and there was no 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 material separation was confirmed.The reported difficult to remove 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 a balloon dilatation catheter encountered resistance during removal over the guide wire resulting in a core separation.Analysis of the returned wire confirmed the core separation at the hypotube.The separated face was bent and jagged, indicating there was likely a kink at this location and subsequent manipulation resulted in a separation.Multiple instances of teflon coating peeled off the proximal core, likely due to interaction with the torque device.The proximal core was visible at the instances where the teflon coating peeled off.There were no remnants of the peeled or flaking teflon on the guidewire.There was no other visible damage noted on the guidewire.In this case, it is likely that a kink near the hypotube contributed to the resistance during removal of the catheter.Manipulation of the wire, when resistance was met, likely contributed to the core separation.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.

• 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: 21756103
• Report Number: 2024168-2025-03420
• Device Sequence Number: 13302540
• Product Code: DQX
• UDI-Device Identifier: 08717648014338
• UDI-Public: (01)08717648014338(11)241118(17)261031(10)4111871
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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 Model Number: 1009660
• Device Catalogue Number: 1009660
• Device Lot Number: 4111871
• 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: 03/18/2025
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 4X20 MM NC TREK NEO BALLOON DILATATION CATHETER
• Patient Sex: Unknown