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

Model Number	B2070-060
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat the left popliteal artery with severe calcification.The calcified popliteal artery stenosis was first dilated with a 5 mm cutting balloon and the 7x60 mm armada 35 percutaneous transluminal angioplasty (pta) catheter was inflated to 10 atmospheres (atm) and the balloon ruptured.Then a 7fr sheath was placed in the right femoral artery and as the ruptured balloon was attempted to be withdrawn, there was resistance.When the catheter was removed, it was noted the balloon had broken inside the patient.On x-ray, one marker was on the right, and the other one was on the left.The sheath was withdrawn to the right and the first marker was retrieved using a 10mm snare.It was noted that there was no balloon but only marker.It was attempted to remove the second marker with the balloon with the snare but this was not successful, so it was decided to trap the marker with the balloon to the external iliac artery with a stent.The marker stopped moving, and the procedure was completed.On (b)(6) 2021, the patient was undergoing pre-scheduled bypass surgery, and after the left common femoral artery was clamped and opened, the balloon catheter was seen there.The balloon was pulled and the balloon was removed completely.The patient did not have the procedure to remove the balloon, but it was removed during the procedure that was needed, regardless of the ruptured and jailed balloon.There were no reported adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
Date of event: estimated date.The device is returning for analysis; however, it has not yet been received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported balloon rupture and separation were confirmed.The difficulty removing was not tested due to the condition of the 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 revealed no indication of a lot specific product quality issue.The investigation determined that the reported difficulties were likely due to case related circumstances.It is likely that the balloon rupture was the result of interaction with the heavily calcified lesion.In addition, the resistance noted during removal and radial separation of the balloon material was likely the result of the ruptured balloon material catching on the introducer sheath during removal.The additional medical intervention to embed the separated balloon material using a stent was related to 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
• 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: 12796899
• Report Number: 2024168-2021-10259
• Device Sequence Number: 5271431
• Product Code: LIT
• UDI-Device Identifier: 08717648155369
• UDI-Public: 08717648155369
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2022

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: 01/31/2024
• Device Model Number: B2070-060
• Device Catalogue Number: B2070-060
• Device Lot Number: 00806G2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2021
• Supplement Date Received by Manufacturer: 12/27/2021
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2020
• 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: 7FR TERUMO SHEATH.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male