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

Model Number	1009660J
Medical Device Problem Codes	Product Quality Problem (1506); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.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.It was reported that the guide wire felt as if it is losing hydrophilicity during use resulting in resistance with balloons and stents in the procedure.Factors that may contribute to a perceived loss of hydrophilicity / resistance with other devices include, but are not limited to, inner diameter of the device, outer diameter of the guide wire, device support, buildup of procedural contaminants, polymer damage, challenging anatomy, and/or damage to the device or guide wire core.Based on the information provided and because the device was not returned for analysis, it is unknown what may have caused the reported difficulties.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.
Event or Problem Description
It was reported that the procedure was to treat a de novo lesion in the descendent posterior artery with moderate calcification and moderate tortuosity.The ht bmw universal 190 cm guide wire (gw) was used in the procedure; however, the gw felt as if the gw was losing hydrophilicity during use resulting in resistance with unspecified balloons and unspecified stents in the procedure causing the gw to become stuck.There was no adverse patient effect reported and no clinically significant delay reported 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: 21862190
• Report Number: 2024168-2025-04018
• Device Sequence Number: 18121960
• Product Code: DQX
• UDI-Device Identifier: 08717648065866
• UDI-Public: (01)08717648065866(11)241008(17)260930(10)4100871
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/17/2025

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 Expiration Date: 09/30/2026
• Device Model Number: 1009660J
• Device Catalogue Number: 1009660J
• Device Lot Number: 4100871
• 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: 03/26/2025
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2024
• 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
• Patient Sex: Unknown