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

Model Number	1001780J-HC
Medical Device Problem Codes	Material Separation (1562); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2024, angioplasty was to be performed on the proximal left anterior descending (lad) artery.A 014 hi-torque balance middleweight guide wire was advanced to capture a migrated unspecified stent.Resistance was noted due to the anatomy and severe angulation occurred.The guidewire became damaged and removed from the patient.The migrated stent was not retrieved and still remained in the patient.On (b)(6) 2024, the patient returned for an ultrasound (arterial doppler) of the left upper limb to check ulnar patency and the migrated stent.However, the distal tip of the guidewire was observed traveling to the upper third of the humeral artery without hemodynamic consequences.On (b)(6) 2024, the patient underwent an intervention procedure.An ablation was performed to attempt capturing the detached guidewire tip radially.However, this was unsuccessful.Another intervention procedure is scheduled for a later date.No other information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
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.The investigation determined the reported difficulties, treatment, and patient effect appear to be related to the operational context of the procedure.It was reported that the guide wire encountered difficult during advancement due to interaction with the patient¿s challenging anatomy.Manipulation of the guide wire, when resistance was met, likely contributed to the reported material deformation and subsequent material separation.The separated portion of the wire remains within the anatomy.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
N/a.

• 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: 20228746
• Report Number: 2024168-2024-10929
• Device Sequence Number: 11611279
• Product Code: DQX
• UDI-Device Identifier: 08717648025983
• UDI-Public: (01)08717648025983(17)250731(10)3082271
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2024

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 Expiration Date: 07/31/2025
• Device Model Number: 1001780J-HC
• Device Catalogue Number: 1001780J-HC
• Device Lot Number: 3082271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2023
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown