MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	1013468-100
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 performed to treat a lesion in the right superficial femoral artery (sfa) with mild calcification and 85% stenosis.The armada 18 balloon catheter was advanced to the target lesion; however, the balloon ruptured at 12 atmospheres (atm).During removal of the balloon catheter, the distal portion of the balloon separated.There was no resistance noted during removal of the balloon catheter.A snare device was able to retrieve the separated portion of the balloon to the iliac and there an omnilink stent was used to compress the balloon against the vessel to secure the separated portion from free floating in the anatomy.There was no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported balloon rupture and separation were confirmed.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 identified no other similar incidents and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported balloon rupture; however, the reported separation, unexpected medical intervention and device embedded in tissue or plaque appear to be related to operational context.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
Event or Problem Description
N/a.

• Brand Name: ARMADA 18 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 15142512
• Report Number: 2024168-2022-08433
• Device Sequence Number: 5504010
• Product Code: LIT
• UDI-Device Identifier: 08717648208201
• UDI-Public: 08717648208201
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K151317
• 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): 09/06/2022

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: 05/31/2025
• Device Model Number: 1013468-100
• Device Catalogue Number: 1013468-100
• Device Lot Number: 1121841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2022
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 08/01/2022
• Supplement Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 64 KG