MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 14 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	A2030-060
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	06/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not expected to be returning for analysis.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat lesions in the right superficial femoral artery (sfa), popliteal artery, right posterior tibial artery and right peroneal artery.After successful atherectomy and stent implantation in the proximal popliteal artery to proximal sfa, atherectomy was performed in the distal peroneal artery, followed by angioplasty using a 3.0 x 60 armada balloon.At an unspecified pressure, the balloon ruptured.Angiography noted a microperforation of the vessel, with small contrast extravasation.Prolonged balloon inflation was performed; however, the perforation persisted so a 4.0 x 19 mm graftmaster stent was implanted, successfully resolving the perforation.The procedure was completed with intervention to the posterior tibial artery.Final angiography noted no dissection, perforation or thrombus present and timi 3 flow.No additional information was provided.
Additional Manufacturer Narrative
The devices was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no indication of a lot specific product quality issue.Based on the information provided, a definitive cause for the reported balloon rupture and vessel dissection could not be determined.It may be possible that the rupture occurred due to interaction with lesion calcified or associated devices; 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: ARMADA 14 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10237611
• Report Number: 2024168-2020-05500
• Device Sequence Number: 2425546
• Product Code: DQY
• UDI-Device Identifier: 08717648156083
• UDI-Public: 08717648156083
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K102705
• 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,Followup
• Report Date (Section B): 08/03/2020

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: 03/31/2023
• Device Model Number: A2030-060
• Device Catalogue Number: A2030-060
• Device Lot Number: 9100341
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 08/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Weight: 123