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

Catalog Number 1014263-040

Device Problems Deflation Problem (1149); Inflation Problem (1310); Failure to Deflate (4060)

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

Event Date 02/27/2023

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a mid superficial femoral artery.The 5.0x150mm armada 18 balloon dilatation catheter (bdc) completely failed to inflate when in the anatomy.However, when the bdc was removed the balloon was inflated and would not deflate outside the anatomy.Another device was used to successfully complete the procedure.There was no adverse patient effects reported and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Manufacturer Narrative

Visual and functional inspections were performed on the returned device.The reported inflation issue was not confirmed; however, the failure deflating the balloon 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 similar incidents and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported inflation issue or failure to deflate.There was no damage reported to the bdc during the inspection prior to use which suggests a product quality issue did not contribute to the reported difficulties.Return analysis noted the shaft was stretched proximal to the proximal seal.In this case, it is possible that the device was inadvertently mishandled during preparation resulting in the noted stretched shaft and subsequently the stretched shaft contributed to the reported inflation issue and failure to deflated; however, this cannot be confirmed.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.Medical device problem code: updated from 1149 to 4060.

• 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: 16594432
• MDR Text Key: 311818404
• Report Number: 2024168-2023-02970
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K151317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1014263-040
• Device Lot Number: 2082441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2022
• 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