MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 14 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	A2030-060
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual and functional inspection was performed on the returned balloon catheter and the reported inflation issue was confirmed.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 identified no other incidents and/or complaints reported from this lot.The device was prepped prior to use without any leak or ruptures noted, which would suggest that the device was not damaged prior to use.The investigation determined the reported inflation issue, noted balloon rupture and balloon scratch appear to be related to operational circumstances of the procedure.Based on the reported information and returned analysis, it is likely that during advancement through the severe calcified and mild tortuosity anatomy the balloon outer surface became damaged resulting in the noted balloon rupture/leak during inflation.The noted scratch at the rupture site also suggests interaction causing damage to the outer surface of the balloon material.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat a lesion with severe calcification and mild tortuosity in the left anterior tibial artery.The 3.0 x 60 mm armada 14 balloon catheter crossed the lesion; however, during an attempt to inflate the balloon to nominal pressure, the pressure did not increase.Therefore, the balloon catheter was removed without issue.A new armada 14 balloon was used successfully.There were no adverse patient effects and no clinically significant delay in the procedure.The returned device analysis identified a pinhole in the balloon material 2.7cm distal to the proximal marker.No additional information was provided.

• Brand Name: ARMADA 14 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11986313
• Report Number: 2024168-2021-04933
• Device Sequence Number: 17333493
• Product Code: DQY
• UDI-Device Identifier: 08717648156083
• UDI-Public: 08717648156083
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K102705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/11/2021

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: 12/31/2022
• Device Model Number: A2030-060
• Device Catalogue Number: A2030-060
• Device Lot Number: 9071641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1