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

Model Number	A1040-060
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.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 should be noted that the percutaneous transluminal angioplasty catheter (pta), armada 14, ce, instructions for use (ifu), states: maintaining vacuum during withdrawal.Gentle counterclockwise twisting motion of the balloon may ease withdrawal through the sheath or from the percutaneous entry site.Do not twist the catheter more than three (3) full turns.If the balloon cannot be withdrawn through the sheath, withdraw the catheter and sheath as one unit.In this case, the physician did not follow the instructions for use.Instead of using gentle counterclockwise twisting motion to remove the device, excessive force was applied resulting in the reported separation.The investigation determined the reported balloon rupture, difficulty removing the device and surgical intervention appear to be related to circumstances of the procedure; however, the reported separation appears to be related to user error/operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a fistula in the arterial venous shunt for hemodialysis.The 4.0x60mm armada 14 balloon dilatation catheter (bdc) was soaked in saline and prepared (air aspiration) outside the anatomy prior to use.There was no resistance during advancement, however, the balloon was inflated two times at 10 atmospheres (atms) and 14 atms and ruptured during the second inflation.There was resistance with the anatomy during removal, force was applied and the balloon tore in a circular way.Surgical intervention was performed to recover the end of the balloon remaining in the anatomy.There was no adverse patient sequela and there was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: ARMADA 14 PTA CATHETER
• Common Device Name: 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: 17099922
• Report Number: 2024168-2023-06107
• Device Sequence Number: 18064885
• Product Code: DQY
• UDI-Device Identifier: 08717648155864
• UDI-Public: 08717648155864
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K102705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: A1040-060
• Device Catalogue Number: A1040-060
• Device Lot Number: 1032341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown