MAUDE Adverse Event Report: ABBOTT VASCULAR RX VIATRAC PLUS; PEREIPHERAL DILATATION CATHETER

Model Number	1008193-20
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	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.The additional ht command device referenced in b5 and d11 is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a renal artery.A 5x20mm viatrac plus balloon was placed over a hi-torque command guide wire, and resistance was met when advancing the balloon over the wire.Therefore, it was decided to remove the balloon, but force had to be applied as resistance was met, and the balloon portion separated.The devices were simply removed altogether and it was confirmed that nothing remained in the anatomy.Another balloon and guide wire were 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
Naconclusion code 18 was removed.
Event or Problem Description
It was reported that the procedure was to treat a renal artery.A 5x20mm viatrac plus balloon was placed over a hi-torque command guide wire, and resistance was met when advancing the balloon over the wire.Therefore, it was decided to remove the balloon, but force had to be applied as resistance was met, and the balloon portion separated.The devices were simply removed altogether and it was confirmed that nothing remained in the anatomy.Another balloon and guide wire were used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequent to filing the initial report, the following additional information was received from the account confirming that the shaft separated, not the balloon portion as initially reported.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported difficulties to remove and advance were not confirmed due to device condition.The noted kink was likely due to case circumstances.The shaft separation was not confirmed but noted on the outer member and inner members.The additional noted damage is attributed to interactions with the anatomy.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 reported from this lot.It should be noted that the viatrac plus instruction for use states: "if resistance is met during manipulation, determine the cause of the resistance before proceeding.'' the investigation determined the reported difficulty to advance and remove the guide wire through the balloon catheter appears to be related to operational circumstances of the procedure.Based on the reported information, it is likely that the inadvertent mishandling of the device during placement caused the shaft of the viatrac plus to become damaged during advancement through the anatomy and/or other devices used resulting in the difficulty to advance/ remove.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: RX VIATRAC PLUS
• Common Device Name: PEREIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10337863
• Report Number: 2024168-2020-06276
• Device Sequence Number: 14223969
• Product Code: LIT
• UDI-Device Identifier: 08717648056987
• UDI-Public: 08717648056987
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K072798
• 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,Followup
• Report Date (Section B): 12/03/2020

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: 12/31/2021
• Device Model Number: 1008193-20
• Device Catalogue Number: 1008193-20
• Device Lot Number: 0011662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 09/24/2020; 11/16/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 10/15/2020; 12/03/2020
• 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: HI-TORQUE COMMAND GUIDE WIRE; HI-TORQUE COMMAND GUIDE WIRE