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

Model Number	1008195-40
Medical Device Problem Codes	Off-Label Use (1494); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned 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 complaints.It should be noted that the indication for use listed in the viatrac plus instruction for use states: the viatrac 14 plus peripheral dilatation catheter is intended to dilate stenosis in the peripheral arteries (iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries).In this case, it could not be determined if the off-label use caused or contributed to the reported difficulties.Based on the information provided, a definitive cause for the reported balloon rupture and separation could not be determined.It may be possible that the rupture occurred due to interaction with lesion calcification or associated devices.Additionally, the separation may have occurred during removal due to the ruptured balloon material catching on the introducer sheath; however, this could not be confirmed.The additional treatment to snare the separated portion of the balloon was due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the carotid artery.A 5.5x40mm viatrac plus peripheral dilatation catheter ruptured during the first inflation at 8 atmospheres and the balloon separated.The separated balloon piece was snared out and the procedure was successfully completed.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

• 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: 9975025
• Report Number: 2024168-2020-03737
• Device Sequence Number: 2740306
• Product Code: LIT
• UDI-Device Identifier: 08717648057083
• UDI-Public: 08717648057083
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K072798
• 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): 04/17/2020

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: 03/31/2021
• Device Model Number: 1008195-40
• Device Catalogue Number: 1008195-40
• Device Lot Number: 9040861
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 04/17/2020
• 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: Required Intervention