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

Model Number	1030902
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562); Stretched (1601); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional ht command device referenced is filed under separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified, 100% stenosed posterior tibial artery, below the knee.A 300cm ht command es guide wire (gw) was advanced to the lesion but could not cross the heavy calcification and was removed without issue.An ht proceed angled guide wire was advanced but failed to cross the lesion.The wire was pulled back to reposition, and resistance was noted.During removal, the wire separated in the anatomy.The coils were separated.A snare was used to remove the separated portions, but the platinum tip could not be removed and remains in the patient anatomy.There was no adverse patient sequela and no clinically significant delay in procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and dimensional inspections were performed on the returned guide wire.The reported stretched coils and tip separation were conformed.The reported failure to advance and entrapment of the device were 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.A cine was received and reviewed by an abbott vascular clinical specialist.The cine review concluded that the ht proceed was reported as utilized to cross heavy calcification within the artery.Resistance was experienced by the physician which is presumed to be the wire lodged in the calcification.The wire then separated during the attempt to remove the wire from the anatomy.It should be noted that electronic instructions for use guide wire hi-torque proceed fda states: carefully observe the instructions under ¿do not¿ and ¿do¿ below.Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage.In this case, the reported ifu violation of use against resistance does not appear to have caused or contributed to the reported complaint.There was no damage or contaminations 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.In this case, based on the reported information and cine review, the investigation determined the reported failure to advance, entrapment of the device, separation and stretched coils appear to be related to operational circumstances of the procedure.During advancement, the guide wire encountered resistance with the challenging anatomy likely caused the tip of the guide wire to lodge in the calcification causing the failure to advance.Manipulation against resistance during retraction resulted in the reported separation stretched coils and subsequent noted damaged to the guide wire.Additionally, the reported treatment appears to be related to the case circumstances as a snare was used to remove the separated portions, but the platinum tip could not be removed and remains in the patient anatomy.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 11609051
• Report Number: 2024168-2021-02689
• Device Sequence Number: 3897983
• Product Code: DQX
• UDI-Device Identifier: 08717648321429
• UDI-Public: 08717648321429
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 03/17/2021
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Weight: 125