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

Model Number	A2025-060
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device and the reported rupture and inflation issues were 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 investigation determined the reported inflation issue and balloon rupture appears to be related to operational circumstances of the procedure.In this case, based on the reported information and returned analysis, it is likely that during advancement the balloon became compromised and/or damaged against the anatomy and or other devices used resulting in the reported balloon rupture and inflation issues.The noted scratch/scratches 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.The additional device referenced has been filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the anterior tibial artery.A 2x120mm armada 14 percutaneous transluminal angioplasty (pta) was advanced without resistance.The balloon completely failed to inflate while losing pressure as a balloon rupture was noted.A 2.5x60mm armada 14 pta was advanced, and the balloon partially inflated only up to 4 atmospheres but was also losing pressure as a pinhole balloon rupture was noted.A 2x60mm armada balloon was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.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: 11454523
• Report Number: 2024168-2021-01905
• Device Sequence Number: 19845992
• Product Code: DQY
• UDI-Device Identifier: 08717648156021
• UDI-Public: 08717648156021
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 03/10/2021

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: A2025-060
• Device Catalogue Number: A2025-060
• Device Lot Number: 9071741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1