MAUDE Adverse Event Report: ABBOTT VASCULAR HT VERSATURN GUIDE WIRE

Model Number	1013319J
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.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 proximal left anterior descending (lad) artery.The versaturn guide wire was advanced distally to the lesion and the tip became caught within calcification in a small branch.It was attempted to retrieve the guide wire but when turning/handling resistance was felt with the anatomy and the tip became separated and released in the artery.The tip is located in the small branch (not in the lad lumen) and was left in the anatomy.The procedure continued successfully with another guide wire.The patient remains in good condition.There was no adverse patient sequela or clinically significant delay.
Additional Manufacturer Narrative
Device code 2017- failure to follow steps/instructions.Visual and dimensional inspections were performed on the returned guide wire, and the reported separation was confirmed.The reported difficulty to advance and remove 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.It should be noted that the instructions for use hi-torque guide wire, pta, ptca, stents, ce, warnings section 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.If resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed.Use the most suitable guide wire for the lesion being treated.Do not push, auger, withdraw, or torque a guide wire that meets resistance.Do not torque a guide wire if the tip becomes entrapped within the vasculature.Although it was reported that the physician torqued the wire during retraction, this was due to the guide wire being trapped in the anatomy, therefore the torquing and pulling/handling during retraction of the guide wire seemed to be a reasonable clinical response to the difficulties.Additionally, a review of the complaint history identified no other incidents reported from this lot.There was no damage noted to the guide wire during the inspection prior to use.The investigation determined the reported difficulty to advance, difficulty to remove and tip separation appear to be related to operational circumstances of the procedure.Torquing and manipulation of the wire against resistance resulted in the tip separation and subsequent noted damages to the wire.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: HT VERSATURN GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9833124
• Report Number: 2024168-2020-02445
• Device Sequence Number: 2871871
• Product Code: DQX
• UDI-Device Identifier: 08717648198496
• UDI-Public: 08717648198496
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2020

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: 12/31/2021
• Device Model Number: 1013319J
• Device Catalogue Number: 1013319J
• Device Lot Number: 0011461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 03/14/2020
• Supplement Report FDA Received Date: 04/16/2020
• 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: Other