MAUDE Adverse Event Report: ABBOTT VASCULAR RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER; PEREIPHERAL DILATATION CATHETER

Model Number	1008197-20
Medical Device Problem Codes	Off-Label Use (1494); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was not returned to abbott vascular 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 revealed no other similar incidents reported for this lot.It should be noted that per instructions for use (ifu), the, viatrac 14 plus, global ce, 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), and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.In this case, use of the device in the wrong anatomy does not appear to have caused or contributed to the reported balloon rupture.The device was prepped prior to use with no issue/ leak noted, which would suggest that the device was not damaged prior to use.The investigation determined the reported balloon rupture appears to be related to operational circumstances of the procedure.In this case, it is likely that during advancement though the heavily tortuous and heavily calcified anatomy, the balloon outer surface became damaged resulting in the reported balloon rupture during the first inflation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The other rx viatrac balloon dilatation catheter referenced is filed under separate a medwatch report number.
Event or Problem Description
It was reported that two viatrac balloon dilatation catheters were prepared without issue.During a heavily tortuous and calcified right internal carotid intervention, both balloons ruptured during the first inflation below the rated burst pressure.Two xact stent systems were advanced, but failed to cross due to the heavily calcified anatomy.The procedure was completed with another rx viatrac plus 6x30 that was able to open up the lesion.There was no adverse patient effect and no clinically significant delay.No additional information was provided.

• Brand Name: RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
• Common Device Name: PEREIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11043508
• Report Number: 2024168-2020-10752
• Device Sequence Number: 11024634
• Product Code: LIT
• UDI-Device Identifier: 08717648057144
• UDI-Public: 08717648057144
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/20/2020

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: 08/31/2022
• Device Model Number: 1008197-20
• Device Catalogue Number: 1008197-20
• Device Lot Number: 0093061
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR