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

Model Number	1030904
Medical Device Problem Codes	Break (1069); Stretched (1601); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a chronically total occluded mid superficial femoral artery.A hi-torque proceed was being advanced when it was noted that there was a longer space (deduced to be stretched) between the core and tip (guide wire still remaining in one piece).There was some resistance noted due to anatomy.However, while attempting to advance, the core coiling would look compressed.It was decided to remove the guide wire.Per the physician, the guide wire remained in one piece and there was no separation noted.Additionally, it was confirmed not to be unraveled.Another proceed guide wire was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Device analysis noted: [a portion of the tip coils stretched, unraveled and separated at the noted bent core.The core was still intact.].
Additional Manufacturer Narrative
The device was returned for analysis.The reported failure to advance was unable to be replicated in a testing environment as it was based on operational circumstances.The reported stretched coils and the reported material deformation were able to be confirmed.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 did not indicate a lot specific quality issue.As there was no reported damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that resistance was met with the total occluded anatomy resulting in the reported failure to advance.Interaction with the total occluded anatomy and/or manipulation of the device resulted in the reported/noted device damages (stretched/unraveled coils, bent/separated core).There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

• Brand Name: HI-TORQUE PROCEED
• 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: 15523295
• Report Number: 2024168-2022-10210
• Device Sequence Number: 6028906
• Product Code: DQX
• UDI-Device Identifier: 08717648321382
• UDI-Public: 08717648321382
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K201834
• 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
• Report Date (Section B): 09/30/2022

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: 01/31/2023
• Device Model Number: 1030904
• Device Catalogue Number: 1030904
• Device Lot Number: 1021661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 10/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2021
• 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 Age: 72 YR
• Patient Sex: Female
• Patient Weight: 58 KG