MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 14 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number A2040-080

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

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

Event Date 08/10/2023

Event Type  malfunction  

Event Description

It was reported that the procedure was performed to treat a lesion in the right anterior tibial artery with mild calcification and a contrast mix of 50% saline and 50% contrast.The 3.0x120mm armada 14 percutaneous transluminal angioplasty (pta) was inflated once and a rupture occurred at 4 atmospheres.It is possible that a piece of the balloon may have remained in the indeflator; however, it was confirmed that nothing remained in the patient.Another 4.0x80mm armada 14 pta was inflated once at 18 atmospheres; however, despite the balloon was in negative held for twenty seconds, could not be deflated.A non-abbott indeflator was used, but the issue persisted and was removed partially deflated but as a single unit.There was resistance during removal with either the piece of balloon or the catheter.Another armada 14 was used to complete the procedure.There were no adverse patient effects and no reported 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.The additional armada device referenced in b5 is filed under separate medwatch report number.H6: 2017 device code clarifier- failure to follow steps / instructions.

Manufacturer Narrative

Visual inspection was performed on the returned device.The reported difficulty to remove could not be replicated in a testing environment as it was based on operational circumstances.The reported deflation problem could not be replicated in a testing environment due to the condition of the returned device.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.It was reported by the account that the bdc was overinflated to 18 atmospheres (atms).It should be noted that the percutaneous transluminal angioplasty (pta), armada 14 xt, over the wire (ot), global instructions for use (ifu) states: balloon pressure should not exceed the rated burst pressure (rbp).The rated burst pressure for this device is 14 atmospheres as indicated on the product label.In this case, it is unknown if the ifu violation caused or contributed to the reported complaint, the investigation was unable to determine a conclusive cause for the reported deflation issue; however, the reported difficulty removing the device appears to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• Brand Name: ARMADA 14 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: 17633759
• MDR Text Key: 322087025
• Report Number: 2024168-2023-09378
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08717648156151
• UDI-Public: 08717648156151
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A2040-080
• Device Lot Number: 2050641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2023
• Initial Date FDA Received: 08/28/2023
• Supplement Dates Manufacturer Received: 09/28/2023
• Supplement Dates FDA Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2022
• 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