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

Model Number	1001780
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Stretched (1601)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/04/2025
Type of Reportable Event	Serious Injury
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 and d10 is captured under a separate medwatch number.
Event or Problem Description
It was reported that the procedure was to treat the first obtuse marginal (om1) and left anterior descending (lad) coronary arteries with 85-95% stenosis and calcification.Left radial access was gained and a 6fr 4.5 guide catheter was advanced and seated coaxially in the ostium of the left main (lm).The blance middleweight (bmw) guide wire was inserted and advanced without difficulty to the distal om1.A 2.5x15 mm trek balloon was used for pre-dilatation and the dragonfly opstar imaging catheter was advanced.One run was successfully imaged.Upon removal of the dragonfly, there was a lot of resistance.The guide wire and dragonfly had to be removed together as a unit.Once outside the anatomy, the wire was found to be frayed and coiled like a ribbon.The anatomy was imaged again with fluoro and a piece of wire was seen in the vessel.A snare was unsuccessful.A 2.75x28 mm xience skypoint stent delivery system (sds) was attempted to be advanced to embed the wire piece into the vessel wall; however, it could not cross.A 2.5 mm trek balloon was ultimately used to tack the wire piece to the vessel wall and a non-abbott stent was implanted.A final oct run was performed with a new dragonfly opstar.Everything looked good at this point.The physician then decided to switch to the lad and finish the procedure.This was successful using two more runs of oct to image the lad.The 2.75 x 28 xience skypoint sds was used on this vessel and crossed with ease.The patient remained stable throughout the procedure.The patient was discharged the next day with no issues.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection, functional testing, and dimensional analysis was performed on the returned device.The stretch and material separation were 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.The subsequent treatment is related to the circumstances of the procedure.It is possible the wire became damaged during insertion, or during exchange of the balloon and or dragonfly catheters.In the exchange the wire coils may have stacked causing the dragonfly and wire to stick together which causing a separation at the tip or core leading and the stretched coil during removal.There is no indication of a product quality issue with respect to the design, manufacture, 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: 23844706
• Report Number: 2024168-2025-12164
• Device Sequence Number: 18631553
• Product Code: DQX
• UDI-Device Identifier: 08717648013836
• UDI-Public: (01)08717648013836(11)250227(17)270131(10)5022771
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Followup
• Report Date (Section B): 02/04/2026

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: 1001780
• Device Catalogue Number: 1001780
• Device Lot Number: 5022771
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2025
• 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: DRAGONFLY OPSTAR IMAGING CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown