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

Model Number	1012068-06
Medical Device Problem Codes	Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the procedure was to treat the left external illiac artery with heavy calcification and heavy tortuosity.The 7x80mm absolute pro self expanding stent was advanced over a 0.035 hi-torque versacore floppy guide wire without resistance.The thumbwheel was engaged and the stent deployed without issues.Upon withdrawal, resistance was felt with the guide wire.Saline was flushed through the absolute pro delivery system using the hydroplane technique, in order to slide the absolute pro delivery system off the guide wire.The guide wire was removed and proximal portion of the wire was noted to be bent yet remained intact.There were no adverse patient effects and no clinically significant delay in the procedure.No additional 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.The additional device referenced in the description of incident is filed under a separate report number.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device.The reported deformation due to compressive stress was confirmed.The reported difficult to remove could not be tested due to the device condition.A review of the production records and the corrective and 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 difficulties.It was reported that the guide wire met resistance with a self-expanding stent (ses) device and upon removal, a bend was noted.Analysis of the returned wire confirmed the reported bend.Factors that may contribute to a bend during use include, but are not limited to, user technique, manipulation against resistance, excessive force applied to device, interaction with accessory devices, and/or interaction with challenging anatomy.In this case, based on the information provided, a conclusive cause for the bend cannot be determined.Additionally, a bend would impact the wires maneuverability through the ses, possibly contributing to the reported difficult to remove.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 VERSACORE
• 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: 19690704
• Report Number: 2024168-2024-08016
• Device Sequence Number: 17926457
• Product Code: DQX
• UDI-Device Identifier: 08717648124204
• UDI-Public: (01)08717648124204(17)250430(10)3051561
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K083706
• 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): 08/13/2024

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: 04/30/2025
• Device Model Number: 1012068-06
• Device Catalogue Number: 1012068-06
• Device Lot Number: 3051561
• 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: 06/14/2024
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 7X80MM ABSOLUTE PRO SELF EXPANDING STENT
• Patient Sex: Unknown