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

Model Number	1009666
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A visual inspection, functional testing, and dimensional analysis was performed on the returned device.The material separation was confirmed.The difficult to remove is related to case conditions and cannot be replicated in a lab environment.Production record and corrective and preventative 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, a definitive cause for the reported issue could not be determined.It was reported the devices were removed by force.It should be noted that the bmw univ ii instructions for use states: if resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed.Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage.In this case, the ifu violation did not contribute to the reported event.It is possible the guide wire tip was twisted due to the tip being caught by calcification causing the shaping ribbon to over twist likely leading to the separation of shaping ribbon from the tip solder when the device was pulled forcibly when he difficult to remove was encountered.This also contributes to the stretched coils.The cause of the difficulty to remove is related to the guidewire possibly becoming caught in the reported calcification.It is unlikely an interaction between the guide wire and the stent system or guideliner had occurred.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported the procedure was to treat a highly calcified lesion in the distal circumflex (cx) artery.A guideline was advanced over the bmw universal ii guide wire which was placed in the cx.A 2.25x33mm rx xience skypoint stent delivery system (sds) was attempted to be advanced however could not advance.When pulling back the sds, the stent became stuck and felt like it was going to dislodge from the balloon.The whole system was removed with force when it was noted the distal part of the guide wire had separated.The separated portion remained in the distal cx as no attempts were made to retrieve the wire.There were no adverse patient sequela and no clinically significant delay in the procedure.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: 24199994
• Report Number: 2024168-2026-00380
• Device Sequence Number: 20207433
• Product Code: DQX
• UDI-Device Identifier: 08717648118739
• UDI-Public: (01)08717648118739(11)250710(17)270630(10)5071071
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/28/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1009666
• Device Catalogue Number: 1009666
• Device Lot Number: 5071071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 68 KG