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

Model Number	1012067-02
Medical Device Problem Codes	Break (1069); Stretched (1601); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the procedure was to treat an unspecified vessel.There was some resistance during use of the ht flex-t guide wire and the device was removed.It was noted upon removal that the tip of the wire had unraveled.The issue occurred with another device from the same lot.There were no adverse patient effects and there was 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 b5 is filed under a separate medwatch report number.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported stretched coils were confirmed.The reported difficult to advance could not be tested due to the device condition.The reported break could not be 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.Fourteen sterile units from the same part and lot were visually inspected, the inspection found no evidence of a product quality issue.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.It was reported that resistance was encountered during advancement of the guide wire.In this case, analysis of the returned wire noted multiple bends on the distal end of the wire.This type of damage is consistent with interaction with the anatomy.It is possible that the wire sustained damage during advancement, impacting its maneuverability and resulted in the difficulty encountered during advancement.Additionally, it is likely that manipulation of the wire, during its difficult advancement, contributed to the reported stretched coils.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.B5 - describe event or problem: updated.
Event or Problem Description
Subsequent to the previously filed report, returned device analysis identified the guide wires were kinked/bent and no breaks were identified.No additional information was provided.

• Brand Name: HI-TORQUE FLEX-T
• 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: 19886095
• Report Number: 2024168-2024-09095
• Device Sequence Number: 18091977
• Product Code: DQX
• UDI-Device Identifier: 08717648124112
• UDI-Public: (01)08717648124112(17)260131(10)4020261
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K083738
• 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): 09/04/2024

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: 1012067-02
• Device Catalogue Number: 1012067-02
• Device Lot Number: 4020261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 08/01/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2024
• 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