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

Model Number	B2070-120
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the heavily calcified superficial femoral artery (sfa).The 7.0 x 120 mm armada 35 dilatation catheter was prepared for use and no issues were noted.The dilatation catheter was advanced to the target lesion without difficulty and the balloon was inflated.The balloon was inflated 1 time to 7 atmospheres (atm) and a rupture occurred.A portion of the balloon separated and during device removal, without difficulty, the separated segment was noted to be in the sheath and did not remain in the patient anatomy.All parts of the balloon were removed without intervention.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
A visual inspection was performed on the returned balloon catheter and the reported balloon rupture and separation were confirmed.The reported difficulty to remove was unable to be confirmed due to the returned 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.Based on the review of similar incidents there is no indication of a lot specific product quality issue.In this case, the device was prepped prior to use without any leak noted, which would suggest that the device was not damaged prior to use.The investigation determined the reported balloon rupture, material separations, and subsequent noted damages appear to be related to case circumstances of the procedure.In this case, it is likely that balloon outer surface became compromised and/or damaged against the heavily calcified anatomy resulting in the reported rupture during the first inflation.The noted scratch/scratches at the rupture site also suggests interaction causing damage to the outer surface of the balloon material.Manipulation during retraction likely caused a portion of the balloon to tear off and separate in the sheath.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 13404977
• Report Number: 2024168-2022-01047
• Device Sequence Number: 19293471
• Product Code: LIT
• UDI-Device Identifier: 08717648155390
• UDI-Public: 08717648155390
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/21/2022

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: 02/28/2025
• Device Model Number: B2070-120
• Device Catalogue Number: B2070-120
• Device Lot Number: 10907G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/10/2022
• Supplement Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2021
• 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 Sex: Unknown