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

Catalog Number	B1080-040
Medical Device Problem Codes	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)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	08/28/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2024168-2023-10191
• Device Sequence Number: 15333529
• Product Code: LIT
• UDI-Device Identifier: 08717648154867
• UDI-Public: 08717648154867
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K111899
• 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,Followup
• Report Date (Section B): 10/27/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2023
• Supplement Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CORDIS 6 FR 13CM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown