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

Model Number	1009660J
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
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 is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a lesion in a 70% stenosed lesion the mid left anterior descending (mlad) artery with moderate calcification.The first ht-bmw universal 190cm j guide wire (gw) was used in the procedure; however, an unspecified stent and an unspecified balloon could not be removed from the gw.Therefore, another ht-bmw universal gw was used to continue the procedure; however, an unspecified stent and an unspecified balloon also could not be removed from the gw.A third gw was used to complete the procedure.There was no adverse patient effect reported and no clinically significant delay reported in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the production records and corrective or preventive actions (capa) 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.The investigation was unable to determine a conclusive cause for the reported difficult to remove.It was reported that a stent delivery catheter and a balloon catheter encountered difficulty during removal over the wire.Factors that may contribute to difficulty removing a catheter over 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, user technique, and/or damage to the catheter or guide wire.Based on the information provided and because the device was not returned for analysis, it is unknown what may have caused the reported difficulty during removal.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.

• 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: 21423304
• Report Number: 2024168-2025-01902
• Device Sequence Number: 7680549
• 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: IT
• 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): 06/24/2025

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): Initial
• Initial Date Received by Manufacturer: 01/28/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 06/24/2025
• 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 Age: 76 YR
• Patient Sex: Unknown