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

Model Number	1011880J
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
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 performed to treat a lesion in the heavily calcified lesion in the left anterior descending (lad) coronary artery.The ht balance middleweight elite guide wire was advanced through the lesion without issues; however, when it was removed from the patient the weld part of the guide wire became caught on the introducer sheath.The guide wire was able to be removed by simply pulling it out.A second ht balance middleweight elite guide wire was advanced, but the same issue occurred during removal even though it was a new introducer sheath.The procedure was successfully completed with a non-abbott guide wire.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual, dimensional, and functional inspection was performed on the returned device.The reported difficult to remove could not be tested as it was based on operational context.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.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.It was reported that the guide wire interacted with an accessory catheter during removal, resulting in the reported resistance during removal.Analysis of the returned device confirmed the outer diameter of the wire was within specification.Additionally, a functional test was performed, advancing and removing the wire through a proxy catheter.The wire passed without resistance.In this case, it is likely a characteristic of the accessory catheter used that contributed to the interaction between the catheter and wire, resulting in the reported resistance 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 ELITE
• 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: 19625740
• Report Number: 2024168-2024-07715
• Device Sequence Number: 8085103
• Product Code: DQX
• UDI-Device Identifier: 08717648144790
• UDI-Public: (01)08717648144790(17)251231(10)4011871
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 10/15/2024

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: 12/31/2025
• Device Model Number: 1011880J
• Device Catalogue Number: 1011880J
• Device Lot Number: 4011871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2024
• 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