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

Model Number	1008193-30
Medical Device Problem Codes	Off-Label Use (1494); Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device is expected to be returned for investigation.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 an unknown carotid artery.The emboshield nav6 embolic protection system (eps) was advanced to the distal end of the stenosis and it was decided by the physician to use a 5x30x135 viatrac 14 plus peripheral dilatation catheter as there was no other suitable balloon to choose during the procedure.The viatrac ruptured at 14 atmospheres and half of the balloon was withdrawn from the anatomy; however, the other half remained on the unspecified guide wire.The balloon left on the guide wire was attempted to be removed with the guiding catheter, but it would not enter the guiding catheter.A separate sheath was advanced in attempt to snare the balloon; however, was unsuccessful.Therefore, the filter and the balloon were removed together with the eps barewire.Another same size viatrac and nav6 were used to successfully complete the procedure.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported material separation was confirmed.The reported material rupture and difficult to remove could not be tested due to the condition of the returned device.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 incidents.The investigation determined the reported difficulties and subsequent treatment appears to be related to the operational circumstances of the procedure.It should be noted that the pdc, viatrac 14 plus, global ce, instructions for use (ifu) 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.It is unknown if the ifu deviation contributed to the reported event.There is no indication of a product quality issue with respect to manufacture, design or labeling.D4: lot number was updated from 1042162 to 1033161.D4: expiration date was updated from 3/31/2023 to 2/28/2023.

• 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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12459750
• Report Number: 2024168-2021-08105
• Device Sequence Number: 19746624
• Product Code: LIT
• UDI-Device Identifier: 08717648056994
• UDI-Public: 08717648056994
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2021

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: 02/28/2023
• Device Model Number: 1008193-30
• Device Catalogue Number: 1008193-30
• Device Lot Number: 1033161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 09/13/2021
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EMBOSHIELD NAV6; EMBOSHIELD NAV6
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown