MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number B1060-150

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device is returning, it has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the armada 35 balloon dilatation catheter was not prepared prior to entering the patient anatomy.The procedure was to treat a lesion located in the superficial femoral artery that was heavily calcified.The armada 35 balloon was advanced to the lesion and during the first inflation ruptured at the rated burst pressure.Removal was difficult and it was noted that the balloon was only partially deflated.A guide wire was advanced subintimal and the balloon catheter successfully removed.A supera stent system was advanced and deployed, successfully establishing flow to the leg.The patient was reported to be doing well.There was no adverse patient sequela and no clinically significant delay in the procedure.

Manufacturer Narrative

Visual analysis was performed on the returned unit.The balloon material rupture was confirmed.The deflation problem, and difficult to remove were unable to be confirmed.Additionally, it was noted that the proximal balloon marker was loose and freely moving on the inner member.There was a separation on the inner member distal to the proximal balloon seal.The material at the noted separations of the inner and outer member was jagged.The separated portion of the balloon, inner and outer member was not returned.There was no other damage noted to the balloon dilatation catheter (bdc).A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other similar complaints.It should be noted that ifu, pta, armada 35 instructions for use (ifu) states: ¿perform the following steps to remove all air and verify the integrity of the pta catheter.1) fill an inflation device/syringe with a mixture of contrast medium and normal saline.2) remove protective tubing from the balloon.3) attach the inflation device/syringe to the connector of the balloon lumen.Hold the catheter with the distal tip pointing downwards.4) open the stopcock to the catheter; pull negative for 30 seconds; release to neutral for contrast fill.5) close the stopcock to the catheter; purge the inflation device/syringe of all air.6) repeat steps 4 through 6 until all air is expelled.7) leave the catheter under negative pressure until the balloon is at the target lesion site.The deviation to not perform preparation may have contributed to the material rupture, however, the likely cause is related to the calcified lesion.Based on the information provided, the balloon rupture and difficult to remove appear to be due to case circumstances.It is likely that the balloon rupture occurred due to interaction with the calcified lesion causing damage to the outer surface of the balloon material leading to the rupture and then the difficult to remove.A conclusive cause for the deflation issue could not be determined.The noted inner member separation, noted dislocated marker, and the reported addition therapy to attempt removal of system were due to the case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ARMADA 35 PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11090301
• MDR Text Key: 224249876
• Report Number: 2024168-2020-10990
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648154744
• UDI-Public: 08717648154744
• Combination Product (y/n): N
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: B1060-150
• Device Catalogue Number: B1060-150
• Device Lot Number: 00316G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention