MAUDE Adverse Event Report: ABBOTT VASCULAR INC. HI-TORQUE BALANCE MIDDLEWEIGHT¿ Guide Wire with HYDROCOAT¿ Hydrophilic Coating; Wire, Guide, Catheter

Model Number	1001780-HC
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Stretched (1601)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the procedure was to treat a lesion in the right coronary artery (rca).The bmw hydro guide wire was used in the procedure.After successfully stenting the lesions, the guide wire was retracted with some resistance.Outside of the anatomy it was noted the guide wire was frayed and the distal tip was missing.Fluoro images confirmed a small portion of the distal tip of the guide wire was wedged under the stent struts.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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 information provided, the investigation determined that the reported issues and subsequent treatment appear to be related to operational context of the procedure.Factors that may contribute to difficulty removing the guide wire include, but are not limited to, inner diameter of the catheter, outer diameter of the guide wire, device support, buildup of procedural contaminants, challenging anatomy, and/or damage to the catheter or guide wire.In this case, it was reported that the guide wire was wedge under the stent struts which likely led to the reported stretched coils and tip separation.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¿ Guide Wire with HYDROCOAT¿ Hydrophilic Coating
• Common Device Name: Wire, Guide, Catheter
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 -280
• 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--462 ; +1(951)914-5259
• MDR Report Key: 50772039
• Report Number: 2024168-2026-03549
• Device Sequence Number: 9471924
• Product Code: DQX
• UDI-Device Identifier: 08717648025969
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1001780-HC
• Device Catalogue Number: 1001780-HC
• Device Lot Number: 5102171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2025
• 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 Sex: Unknown