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

Model Number	1008201-20
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Evaluation is not yet complete.A follow-up report will be submitted with all additional relevant information.The herculink elite referenced is filed under a separate medwatch report number.Sus voluntary report mw5098900.
Event or Problem Description
User facility medwatch report received that states: the patient had left subclavian stenosis involving the ostium of the left vertebral artery.To induce retrograde vertebral flow throughout the case, the operating physician opted to place a moma device within the proximal subclavian artery.The distal balloon was removed and only the proximal occlusion was performed.After stabilizing the moma device, the proximal balloon was inflated in the very proximal left subclavian ensuring retrograde flow to the left vertebral.The left subclavian artery was successfully stented with a rx herculink elite 7 x 15 stent.Upon removal of the initial herculink stent balloon the balloon ruptured and a very small portion of the distal balloon may have been sheared off by moma device.However, no evidence of embolization was noted.The patient tolerated the procedure well without complications and was notified by the physician.Fda safety report id # (b)(4).The device returned to abbott with the user facility medwatch report was a 7x20 mm viatrac 14 balloon dilatation catheter.Analysis of the device observed a balloon rupture.No additional information was provided.
Additional Manufacturer Narrative
A visual and functional inspection was performed on the balloon catheter and the balloon rupture 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 revealed no other similar incidents reported for this lot.Balloon material ruptures can be affected by numerous factors such as balloon damage during processing of the balloon material, inflation technique, inflation over rated burst pressure, interactions with other devices, anatomical conditions, a previously implanted stent or insufficient preparation prior to use.The device was prepped prior to use without any leak or ruptures noted, which would suggest that the device was not damaged prior to use.Based in the limited information provided, the investigation was unable to determine a conclusive cause for the reported balloon rupture.It is possible that during inflation the balloon outer surface became damaged or punctured against the anatomy and/or other devices used in the procedure resulting in the balloon rupture; however, this could not be confirmed.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: 11729617
• Report Number: 2024168-2021-03554
• Device Sequence Number: 19692423
• Product Code: LIT
• UDI-Device Identifier: 08717648057304
• UDI-Public: 08717648057304
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2021

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: 02/28/2022
• Device Model Number: 1008201-20
• Device Catalogue Number: 1008201-20
• Device Lot Number: 0033161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 7.0X15 MM HERCULINK ELITE STENT; MOMA EMBOLIC PROTECTION DEVICE
• Patient Age: 61 YR