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

Catalog Number B1080-040

Device Problems Failure to Fold (1255); Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 08/28/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: medical device code 2017 - excessive forcena.

Event Description

It was reported that the procedure was performed to treat an in-stent restenosis lesion in the external iliac artery with moderate calcification and 50% stenosis.The 8x40mm armada 35 percutaneous transluminal angioplasty (pta) catheter was inflated once for five seconds and a rupture occurred below nominal pressure.After the rupture, the markers were noted further away than 40mm apart from each other.There was a lot of difficulty during removal as the balloon did not wrap back up [fold]; therefore, the tip of the sheath was u-shaped, slightly kinked and the entry of the distal tip was very dented making the removal harder.The sheath top was noted damaged after forceful removal and the markers were taken out through the sheath as they separated from each other.There was a possible thrombus at the rupture site and aspiration was performed, confirming the thrombus.As treatment, percutaneous transluminal angioplasty (pta) was performed, no peripheral embolisms were found.There was a delay in the procedure and more radiation exposure; however, there were no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

Visual inspection was performed on the returned device.The reported balloon rupture, kink, and failure to fold were confirmed.The reported separated markers were not returned separated; however, they were loose on the inner member, which is likely what was perceived as separated by the account.The reported difficulty to remove could not be replicated in a testing environment as it was based on operational circumstances.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 of the reported lot did not indicate a lot specific quality issue.Extra force was applied to remove the device.It should be noted that the percutaneous transluminal angioplasty catheter (pta), armada 35/ armada 35ll global, ce, instruction for use (ifu) states: maintaining a vacuum in the balloon, withdraw the catheter.Note: gentle counterclockwise twisting motion of the balloon may ease withdrawal through the sheath or from the percutaneous entry site.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, force was applied resulting in the reported separation.The investigation was unable to determine a conclusive cause for the reported balloon rupture; however, the reported failure to fold, difficulty removing the device, kink, delay in treatment/therapy and unexpected medical intervention appear to be related to circumstances of the procedure.The reported separation appears to be related to use error/operational context.A conclusive cause for the reported patient effect of thrombosis and the relationship to the device, if any, cannot be determined.The reported patient effect of thrombosis is listed in the percutaneous transluminal angioplasty (pta) catheter, armada 35 / armada 35 ll, global ifu, as a known patient effect.There is no indication of a product quality issue with respect to 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
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 17769404
• MDR Text Key: 323679384
• Report Number: 2024168-2023-10191
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648154867
• UDI-Public: 08717648154867
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K111899
• 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: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: B1080-040
• Device Lot Number: 21101G2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2022
• 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
• Treatment: CORDIS 6 FR 13CM
• Patient Outcome(s): Required Intervention