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

Model Number	1008201-20
Medical Device Problem Codes	Off-Label Use (1494); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was received.Investigation is not yet complete.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 a carotid artery.The viatrac balloon was advanced without issue to the target lesion.During the first inflation at an unspecified atmosphere, the balloon completely separated from the catheter, however, was able to be retrieved via snare.There was no adverse patient sequela and no clinically significant delay.No additional information.
Additional Manufacturer Narrative
Visual and sem inspection/analysis was performed on the returned device.The reported separation was confirmed.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/complaints from this lot.The balloon was ultimately sent to the scanning electron microscopy (sem) lab for further analysis.The sem report determined the balloon and inner member separations may possibly be attributed to a material/processing discrepancy and/or exposure conditions.Tearing, along with some areas of smearing, were documented at the rupture edges of the balloon.Slight surface damage was also documented on the od surface adjacent to the rupture edge.The inner member separation had a slightly necked appearance with torn and stretched material, suggesting tensile loading influenced the failure mechanism.An exact balloon rupture origin could not be determined and may be located on the distal half of the separation which was not returned for analysis.It was reported that the procedure was to treat a carotid artery.It should be noted the peripheral dilatation catheters (pdc), viatrac 14 plus, global, information 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).For the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.The investigation was unable to determine a conclusive cause for the reported separation or noted balloon rupture on the returned device; however, the reported unexpected medical intervention and removal of foreign body appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respects 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
• 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: 15662337
• Report Number: 2024168-2022-10984
• Device Sequence Number: 2748665
• Product Code: LIT
• UDI-Device Identifier: 08717648057304
• UDI-Public: 08717648057304
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2022

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: 03/31/2024
• Device Model Number: 1008201-20
• Device Catalogue Number: 1008201-20
• Device Lot Number: 2042761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown