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

Model Number B2050-120

Device Problems Inflation Problem (1310); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 the procedure was to treat a right superior femoral artery (sfa).A 5.0x120mm armada 35 catheter was attempted to be advanced, but the balloon could not cross the tortuous iliac through left common femoral artery.The physician re-inserted same device through the other access site and was able to access the lesion with the balloon via foot access.Once at the lesion unknown pressure was added once, but the balloon failed to inflate.Another unspecified device was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay.No additional information was provided.*device analysis noted there were multiple tears throughout the entire length of the balloon.*the affiliate confirmed at the end of the procedure there were multiple tears visible throughout the entire length of the balloon.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported inflation problem was not confirmed.The difficulty to advance was confirmed based on device condition.The noted tears on the balloon were likely contributors of case circumstances.The investigation determined the reported inflation issue appears to be related to circumstances of the procedure as it is likely the result of accessing the lesion with the balloon via foot access.Difficulty to advance the device met the tortuous anatomy.The tears throughout the entire length of the balloon likely occurred due to interaction with the anatomy.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6- 2017 reinsertion was 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: 10474550
• MDR Text Key: 205187515
• Report Number: 2024168-2020-07249
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648155215
• UDI-Public: 08717648155215
• 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: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• 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 Model Number: B2050-120
• Device Catalogue Number: B2050-120
• Device Lot Number: 00121G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Date Manufacturer Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 106