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

Model Number	1030902
Medical Device Problem Codes	Break (1069); Failure to Advance (2524); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a 90% stenosed heavily calcified lesion in the mildly tortuous posterior tibial artery.A 170t 3cm angled ht proceed guide wire (gw) was advanced into the anatomy but met resistance with the 014 non-abbott crossing support catheter.Due to the resistance, the wire was pulled back and removed.It was noted that about 3cm of the proximal tip of the wire was broken but not completely separated.An 014 command wire was then used to successfully complete the procedure.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 break was confirmed.The reported difficulty to advance was unable to be confirmed due to the returned condition of the guide wire.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.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 through the support catheter and tip/coil break appear to be related to operational circumstances of the procedure.Based on the reported information, the guide wire encountered resistance while advancing with the support catheter through the challenging anatomy.It is likely that the 90% stenosed heavily calcified mildly tortuous anatomy was the cause of the reported difficulty to advance the guide wire through the support catheter.Further manipulation against resistance during retraction likely resulted in the reported/noted coil/tip break and coil damages.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6: medical device problem code 2524 - removed.

• 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: 11936270
• Report Number: 2024168-2021-04658
• Device Sequence Number: 11818853
• Product Code: DQX
• UDI-Device Identifier: 08717648321429
• UDI-Public: 08717648321429
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 06/29/2021

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: 09/30/2022
• Device Model Number: 1030902
• Device Catalogue Number: 1030902
• Device Lot Number: 0100261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 014 CSI CATHETER