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

Catalog Number 1014253-200

Device Problems Inflation Problem (1310); Leak/Splash (1354)

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

Event Date 06/08/2021

Event Type  malfunction  

Manufacturer Narrative

The device was received.Visual and functional inspections were performed on the returned device and the reported inflation problem was confirmed due to a tear on the inner member.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 similar incidents and/or complaints reported from this lot.Factors that may contribute to inflation problems may include, but are not limited to, manufacturing, damage to the device, inner diameter of wire lumen causing resistance and damage, contamination in the inflation lumen, patient anatomical morphology, patient disease state, inflation technique, inadequate/loose connection to the inflation device, and/or accessory device support.The investigation was unable to determine a conclusive cause for the noted inner member tear which resulted in the reported inflation issue.It is possible that the guide wire was inserted at an angle resulting in the inner member tear; however, this could not be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

It was reported that the procedure was to treat a lesion located in the tibial artery that was non-calcified and non-tortuous.The armada 18 was advanced to the lesion and during inflation, the balloon would not inflate past 6 atmospheres (atm).There were no reported adverse patient effects and no clinically significant delay in the procedure.Another armada was used to complete the procedure.Device analysis revealed the balloon catheter would not inflate, and there was fluid observed coming out from a tear in the inner member proximal to the proximal balloon seal.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: 12242883
• MDR Text Key: 264082846
• Report Number: 2024168-2021-06621
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K151317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• 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 Catalogue Number: 1014253-200
• Device Lot Number: 0020441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1