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

Model Number	B1050-150
Medical Device Problem Codes	Material Rupture (1546); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.Na.
Event or Problem Description
It was reported that during an intervention, the armada 35 balloon ruptured when it was inflated to nominal pressure only.No additional information was provided.
Event or Problem Description
Subsequent to the initially filed report, it was reported that the procedure was to treat the distal right-sided superficial femoral artery (sfa) occlusion.It was not very tortous but there were diffuse calcifications that were visible on fluoroscopy.There was some resistance with some calcium during advancement and the balloon was inflated once to 8 atmospheres and ruptured.Another 5x150 mm armada was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual, functional and scanning electron microscopy (sem) analysis were performed on the returned device.The reported balloon rupture was confirmed.An attempt was made to inflate the balloon; however, fluid was leaking from the hub.There was a tear noted in the inner member at the inflation port section of the balloon dilatation catheter (bdc).The difficult to advance cannot be confirmed in a lab environment as this is related to the circumstances of the procedure.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 revealed no other complaints reported from this lot.Sem was performed to analyze the seal leak.The results noted that the leak failure may be attributed to delamination of the inner member to balloon surface.Based on the information provided, the cause for reported the difficult to advance and balloon rupture cannot be determined.It is possible the difficulty identified during insertion contributed to weakening the joint leading to delamination under pressure inducing the leak; however, this cannot be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.E1 - initial reporter information was updated from unk to physician dr.(b)(6).

• 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: 15660524
• Report Number: 2024168-2022-10977
• Device Sequence Number: 5716027
• Product Code: LIT
• UDI-Device Identifier: 08717648154652
• UDI-Public: 08717648154652
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: B1050-150
• Device Catalogue Number: B1050-150
• Device Lot Number: 20120G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2022
• Supplement Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2022
• 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
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 65 KG