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

Model Number 1013470-080

Device Problems Failure to Fold (1255); Defective Device (2588); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/24/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2021, a percutaneous intervention was performed on the right superficial femoral artery (sfa), mildly calcified lesion. An armada dilatation catheter advanced to the lesion without issue and dilatation was performed. During inflation, the proximal shoulder of the balloon, beyond the markers, appeared longer than expected at 10-15mm. The device was removed without issue and a stent placed. The same armada dilatation catheter went to advance; however, resistance during advancement was felt within the sheath. Reportedly, the same armada balloons re-wrap (folding) did not appear normal. The device was removed without issues and another device was successfully used in replacement. There were no adverse patient effects and there was no clinically significant delay. No additional information was provided regarding this issue.

• 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: 12632906
• MDR Text Key: 276407959
• Report Number: 2024168-2021-09227
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/19/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1013470-080
• Device Catalogue Number: 1013470-080
• Device Lot Number: 0111141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial