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

Catalog Number 1014254-150

Device Problem Material Rupture (1546)

Patient Problem Insufficient Information (4580)

Event Date 03/26/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to abbott vascular for analysis.Return of the device may have further aided the 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 incidents and/or complaints reported from this lot.Possible factors that may contribute to balloon leaks or pinhole ruptures may include, but are not limited to, 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 noted, which would suggest that the device was not damaged prior to use.The investigation was unable to determine a conclusive cause for the reported balloon rupture.It is possible that during advancement or multiple inflations the outer surface of the balloon became compromised or damaged against the anatomy and/or other devices used resulting in pinhole balloon rupture and the appearance of a balloon leak; 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 to treat a lesion located in the tibial artery that was moderately calcified.The armada 18 balloon catheter was advanced to the lesion and after an unknown number of inflations, the balloon material was noted to have a leak.The device was removed from the patient.There were no reported adverse patient effects and no clinically significant delay in the procedure.Another balloon was used to continue the procedure.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: 11697935
• MDR Text Key: 264117374
• Report Number: 2024168-2021-03334
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K151317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 1014254-150
• Device Lot Number: 0012241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2020
• 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