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

Model Number 1013466-040

Device Problem Failure to Fold (1255)

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

Event Date 05/04/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis. 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 was unable to determine a cause for the reported difficulty. It may be possible that the balloon folds became compromised after the first inflation and removal causing difficulty during the attempt to re-fold for re-insertion; however, this could not be confirmed. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device. Na.

Event Description

It was reported that the procedure was to treat a left av fistula. During re-insertion into the sheath, the re-wrap of the 4. 0x40mm armada 18 balloon was loose, and re-insertion into the sheath was difficult. Eventually the balloon was able to be re-introduced into the sheath. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.

• 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: 11860596
• MDR Text Key: 251977208
• Report Number: 2024168-2021-04293
• 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: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 05/20/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1013466-040
• Device Catalogue Number: 1013466-040
• Device Lot Number: 0121441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial