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	08/06/2025
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 & d10 is filed under separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat lesions in the left anterior descending (lad) and left main (lm) arteries.After rotablation, the 3.5x20mm nc trek neo balloon dilatation catheter (bdc) was advanced on a hi-torque bmw universal 190cm guide wire (gw).The bdc was used in the procedure; however, when attempting to deflate the balloon for 2-3 seconds, the balloon would not fully deflate.An attempt was made to remove the bdc from the gw; however, the device could not be removed from each other and resistance was noted between the devices.After, several attempts the physician was able to removed the partially deflated balloon with the gw and 7 fr guide catheter (gc) as as a single unit.The procedure was continued with another nc trek neo bdc.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported difficult to remove and the reported material separation were able to be confirmed.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other incidents from this lot.As there was no damage noted to the guide wire during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the reported 3.5 x 20mm nc trek neo deflation difficulties resulted in the reported difficult to remove the guide wire.Manipulation of devices resulted in the noted guide wire damages (multiple kinks on the proximal end of the guidewire, bent distal core) and ultimately resulted in the reported/noted material separation.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
Subsequent to the initial report being filed, it was reported that the hi-torque bmw universal 190cm guide wire (gw) separated at the hypotube during the difficulty removing the 3.5 x 20mm nc trek neo balloon dilatation catheter (bdc) from the gw.No additional information was provided.

• 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: 22910186
• Report Number: 2024168-2025-09178
• Device Sequence Number: 9055019
• Product Code: DQX
• UDI-Device Identifier: 08717648014338
• UDI-Public: (01)08717648014338(11)250508(17)270430(10)5050872
• 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): 11/04/2025

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: 5050872
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2025
• 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: 7-FR. GUIDE CATHETER; NC TREK NEO RX 3.50 X 20MM
• Patient Sex: Unknown