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

Model Number	1008189-20
Medical Device Problem Codes	Off-Label Use (1494); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
Type of Reportable Event	Malfunction
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.The other viatrac dilatation catheter referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the moderately calcified, 80% stenosed internal carotid artery.The first 4.0 x 20 mm viatrac dilatation catheter was advanced to the lesion without issue; however, during the first inflation to 6 atmospheres (atm), leaking was noted.The device was removed.A second 4.0 x 20 mm viatrac dilatation catheter was advanced to the lesion without issue; however, leaking was also noted when inflated to 6 atm.The device was removed and the procedure was completed using an additional dilatation catheter of the same size.There were no adverse patient effects or clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
H6: medical device problem code 1494 - incorrect anatomy.A visual and functional inspection was performed on the balloon catheter and the balloon rupture was confirmed.It was noted to be a pinhole rupture.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the review of similar incidents, there is no indication of a lot specific product quality issue.In this case, the device was prepped prior to use without leaks or ruptures noted, which would suggest that the device was not damaged prior to use.It should be noted that the instructions for use (ifu), pdc, viatrac 14 plus, 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 (internal carotid artery) does not appear to have contributed to the reported balloon rupture.The investigation determined the reported balloon rupture appears to be related to operational circumstances of the procedure and likely due to the anatomical conditions.It is likely that during inflation, the balloon outer surface became damaged and/or punctured against the moderately calcified, 80% stenosed anatomy resulting in the noted balloon pinhole rupture.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 12200078
• Report Number: 2024168-2021-06272
• Device Sequence Number: 3671001
• Product Code: LIT
• UDI-Device Identifier: 08717648056826
• UDI-Public: 08717648056826
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K072798
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

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: 11/30/2022
• Device Model Number: 1008189-20
• Device Catalogue Number: 1008189-20
• Device Lot Number: 0120861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1