MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE INFILTRAC; WIRE, GUIDE, CATHETER

Model Number	1030003J
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	11/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported this was a procedure to treat a mildly tortuous right coronary artery.An infiltrac 3/190cm guide wire was inserted into the anatomy.It was noted that resistance was felt as it was an in-stent restenosis occlusion.During advancement, the guide wire tip separation into two pieces.Although the tip separated, the entire guide wire was able to be removed without performing intervention.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned guide wire and the reported separation was confirmed.The reported difficulty to advance was unable to be replicated in a testing environment as it was based on operational circumstances.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints reported from this lot.There was no damage noted to the guide wire during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation determined the reported difficulty to advance and tip separation appear to be related to case circumstances of the procedure.Based on the reported information, resistance was noted during advancement caused through the in-stent restenosis occlusion causing the difficulty to advance.Further manipulation against resistance likely caused damage to the tip core and coils ultimately resulting in the reported tip/coil separation and noted coils damages.The reported tip separation was likely the noted coil separation.Corrosion was noted on the guide wire and likely a result of exposure to the elements during transit back to abbott vascular for analysis.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE INFILTRAC
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 12908859
• Report Number: 2024168-2021-10918
• Device Sequence Number: 20038839
• Product Code: DQX
• UDI-Device Identifier: 08717648233715
• UDI-Public: 08717648233715
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K193126
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2022

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: 09/30/2022
• Device Model Number: 1030003J
• Device Catalogue Number: 1030003J
• Device Lot Number: 0100161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2020
• 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: IMPLANTED STENT
• Patient Sex: Unknown