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 Consequences Or Impact To Patient (2199)
Date of Event	10/21/2020
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.Additionally, a review of the complaint history identified no other incidents and/or complaints reported from this lot.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 challenging anatomical conditions which were reported as 100% stenosed, likely resulted in the reported failure to advance and difficulty to remove.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that this was a procedure to treat an occluded tibial peroneal trunk artery, below the knee with heavy calcification and heavy tortuosity that was 100% stenosed.A hi-torque proceed guide wire (gw) could not cross the target lesion due to the heavy calcification and resistance with the anatomy was noted during removal.Then two fielder asahi guidewires were used.However, these guide wires could not cross the target lesion also due to the anatomical challenges.Therefore, the physician re-shaped the hi-torque proceed guide wire, and used a secondary bend.The gw was re-inserted but still could not cross the target lesion due to the anatomy.The gw was removed without issue.Another hi-torque proceed guide wire was used, and this gw was successfully advanced.The target lesion was treated and the patient is stable.No other issues noted.There were no adverse patient effects and no clinically significant delay in the procedure.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: 10780276
• Report Number: 2024168-2020-09191
• Device Sequence Number: 3246635
• Product Code: DQX
• UDI-Device Identifier: 08717648321429
• UDI-Public: 08717648321429
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K201834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/03/2020

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: 08/31/2022
• Device Model Number: 1030902
• Device Catalogue Number: 1030902
• Device Lot Number: 0092261
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1