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

Model Number	1030902
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned to abbott vascular for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the review of similar incident(s) there is no indication of a lot specific product quality issue.The investigation determined the reported failure to advance and difficulty to remove appear to be related to operational circumstances of the procedure.Based on the reported information, during advancement the guide wire encountered resistance with the heavily calcified lesion causing the failure to advance.It is likely that during retraction, the guide wire became trapped or caught in the lesion.Manipulation against resistance likely caused calcium to detach but remain on the coils resulting in the difficulty to remove through the guiding catheter.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that the procedure was performed to treat a target lesion in heavily calcified peroneal artery.The ht proceed guide wire was advanced; however, resistance was met with the calcification in the target vessel.The guide wire was unable to advance to the target lesion.An attempt was made to remove the guide wire; however, it could not be pulled into the guide catheter.The.014 guide catheter was exchanged for a.035 guide catheter.The guide wire was then able to be removed.It was noted that a large piece of calcification was caught on the guide wire coils and it was assumed that this was causing the difficult removal.There was no adverse patient effect and no clinically significant delay.No additional information was provided.

• Brand Name: HI-TORQUE PROCEED
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12184387
• Report Number: 2024168-2021-06155
• Device Sequence Number: 924807
• Product Code: DQX
• UDI-Device Identifier: 08717648321429
• UDI-Public: 08717648321429
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/16/2021

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: 12/31/2022
• Device Model Number: 1030902
• Device Catalogue Number: 1030902
• Device Lot Number: 1012761
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 07/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1