MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number B1040-100

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 12/11/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

During the device preparation of a 4 x 100mm armada 35, it was noted that more air bubbles were observed than usual during air aspiration.The physician stopped using the device suspecting the possibility of a leak.The armada 35 was not used and there was no patient involvement.Another armada 35 was used to successfully complete the procedure.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

A visual and functional inspection was performed on the returned device and the reported leak was unable to be confirmed as the device was able to inflate and hold pressure without any leaks noted.Additionally, it was not guaranteed that the correct device had returned.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 leaks during preparation may include, but are not limited to, manufacturing, damage to the balloon, damage to the inflation lumen, incorrect prep, damaged to inflation device, hub cracks, or loose connections.The investigation was unable to determine a conclusive cause for the reported balloon leak during prep.It is possible that the connection between the inflation device and hub was not securely connected resulting in the reported leak or bubbled during preparation; however, this could not be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

• Brand Name: ARMADA 35 PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11067440
• MDR Text Key: 223601868
• Report Number: 2024168-2020-10915
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648154546
• UDI-Public: 08717648154546
• Combination Product (y/n): N
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: B1040-100
• Device Catalogue Number: B1040-100
• Device Lot Number: 90218G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1