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

Model Number 1013470-100

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis.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 similar incidents and/or complaints reported from this lot.Balloon material ruptures can be affected by numerous factors such as balloon damage during processing of the balloon material, materials, inflation technique, inflation over rated burst pressure, interactions with other devices, anatomical conditions, a previously implanted stent or insufficient preparation prior to use.The investigation was unable to determine a conclusive cause for the reported balloon rupture.It is possible that during advancement the balloon became compromised and/or damaged against the heavily calcified anatomy and/or other devices used in the procedure resulting in the reported balloon rupture; however, this could not be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was performed to treat a target lesion in the heavily calcified right superficial femoral artery (sfa).The device was advanced to the target lesion without difficulty.During the first inflation, the balloon ruptured at 6 atmospheres (atm).There was no adverse patient effect or clinically significant delay.There was no resistance noted during withdrawal and all portions of the device were removed.A second armada dilatation catheter was used without issue.No additional information was provided.

• Brand Name: ARMADA 18 PTA CATHETER
• Type of Device: 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: 11121299
• MDR Text Key: 225336768
• Report Number: 2024168-2021-00112
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648208423
• UDI-Public: 08717648208423
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 1013470-100
• Device Catalogue Number: 1013470-100
• Device Lot Number: 0062241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 65