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

Model Number	1012068-09
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to use when removing the 260cm ht versacore guide wire from the dispenser hoop with no resistance, the green/white transition area of the wire became separated, but not confirmed in two pieces.Another versacore guide wire was used to complete the procedure.There was no patient involvement and no reported clinically significant delay in 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.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported break was confirmed as an irregular appearance between the coils and proximal jacket.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 after unpacking the wire, a break was observed.Analysis of the returned wire confirmed the break as a gap between the coils and proximal jacket.This type of damage can occur when the device is inadvertently mishandled during unpacking or preparation.The blood on the device and the bends on the shaping ribbon indicate the device was subject to handling, it is possible this contributed to the noted gap.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: 19763940
• Report Number: 2024168-2024-08463
• Device Sequence Number: 8506754
• Product Code: DQX
• UDI-Device Identifier: 08717648124235
• UDI-Public: (01)08717648124235(17)260131(10)4021461
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 09/17/2024

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: 01/31/2026
• Device Model Number: 1012068-09
• Device Catalogue Number: 1012068-09
• Device Lot Number: 4021461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2024
• 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