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

Model Number	1013319J
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Codes	Bradycardia (1751); Transient Ischemic Attack (2109)
Date of Event	10/31/2024
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 the procedure was to treat a moderately calcified lesion in the right coronary artery (rca).The versaturn guide wire (gw) was advanced to the target lesion and attempts were made to advance a 2.50x15mm and 1.20x20mm balloon catheter to the narrowed vessel however were unsuccessful.During changing position of the gw the tip was noted to hook on the atherosclerotic plaque, resulting in the tip stretching.During these manipulations, a transient decrease in bp 60/40 and bradycardia occurred.The pressure was equalized by administering 1mg of atropine and 500ml of 0.9%.After the patient¿s blood pressure was equalized, symptoms of insufficient cerebral circulation were observed.It was decided to discontinue the procedure at this point.The "patient's" symptoms last approximately 5 minutes post procedure.There were no adverse patient sequela and 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 stretched coils were confirmed.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.Additionally, a conclusive cause for the reported patient effects cannot be determined.It was reported that the guide wire interacted with the patient¿s moderately calcified lesion, resulting in the reported stretched coils.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE VERSATURN
• 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: 20744782
• Report Number: 2024168-2024-13787
• Device Sequence Number: 15615398
• Product Code: DQX
• UDI-Device Identifier: 08717648198496
• UDI-Public: (01)08717648198496(17)260630(10)4071971
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K141782
• 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): 01/16/2025

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: 06/30/2026
• Device Model Number: 1013319J
• Device Catalogue Number: 1013319J
• Device Lot Number: 4071971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6F VASCULAR SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White