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

Model Number B2050-150

Device Problems Stretched (1601); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that this was a procedure to treat a highly stenosed right popliteal artery.The armada 35 balloon catheter was inserted and attempted to be advanced.However, during advancement, the shaft became stretched.The physician decided to remove the device and replace it.It was noted that there were no issues during removal.No adverse patient effects occurred and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported difficulty advancing was unable to be confirmed due to the condition of the returned device.The reported stretching 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 identified no other complaints reported from this lot.The investigation determined that the reported difficulties were due to circumstances of the procedure.It is likely that anatomical conditions contributed to the reported difficulty advancing as the lesion site in the right popliteal artery was described as highly stenosed.Additionally, it is likely that during the difficulty advancing, the stretching and bunching noted on the inner member and outer member occurred.There is no indication of a product quality issue with respect to the design, manufacture, 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: 11039772
• MDR Text Key: 225804426
• Report Number: 2024168-2020-10713
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648155222
• UDI-Public: 08717648155222
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: B2050-150
• Device Catalogue Number: B2050-150
• Device Lot Number: 91108G2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 51