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

Model Number B1070-040

Device Problem Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 06/12/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that during preparation of the armada 35, during filling with contrast, a leak was noticed in the shaft just in front of the proximal part of balloon.The device was not used.There was no patient involvement and no clinically significant delay in procedure.No additional information was provided.

Event Description

Subsequent to the previously filed report, additional information received stated the leak was noticed when inflating the device in the lesion.No additional information was provided.

Manufacturer Narrative

Visual, functional and scanning electron microscopy (sem) analysis was performed on the returned device.The reported leak was confirmed.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 of the reported lot revealed no other similar complaints reported from this lot.Based on this evaluation, a potential product quality issue has been identified.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.H6: patient code 2645 - removed.

• 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: 10478057
• MDR Text Key: 205151186
• Report Number: 2024168-2020-07269
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648154782
• UDI-Public: 08717648154782
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: B1070-040
• Device Catalogue Number: B1070-040
• Device Lot Number: 00224G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 10/23/2020
• Supplement Dates FDA Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1