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

Model Number	22339MJ
Medical Device Problem Codes	Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the right coronary artery (rca) with 90-95% stenosis, moderate calcification and mild tortuosity.The hi-torque (ht) floppy ii guide wire had resistance during advancement with the calcium but reached the target lesion and separated into two pieces.A snare device was used to remove the separated portion.There was no adverse patient sequelae.Another non-abbott guide wire was exchanged to complete the procedure.There was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported material separation was confirmed.The reported difficult to advance 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 and treatment appear to be related to the operational context of the procedure.It was reported that the guide wire met resistance with the patient¿s moderately calcified, mildly tortuous, and 90-95% stenosed lesion, resulting in the difficulty during advancement.It is likely that manipulation of the wire, when resistance was met, contributed to the reported separation.The separated portion of the wire was removed using a snare.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 FLOPPY
• 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 # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 20845111
• Report Number: 2024168-2024-14252
• Device Sequence Number: 19772921
• Product Code: DQX
• UDI-Device Identifier: 08717648080135
• UDI-Public: (01)08717648080135(17)250430(10)3051161
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K881897
• 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): 01/23/2025

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: 04/30/2025
• Device Model Number: 22339MJ
• Device Catalogue Number: 22339MJ
• Device Lot Number: 3051161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2023
• 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: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 80 KG