MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	1013468-060
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	08/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.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 similar incidents and/or complaints from this lot.The investigation determined the reported complaints appear to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a 100% stenosed and heavily calcified vessel in the peroneal trunk.The 5.0x60mm armada 18 percutaneous transluminal angioplasty (pta) balloon catheter was advanced with resistance noted with the anatomy.The balloon burst on the first inflation at 8 atmospheres (atms).Another armada 18 was used to complete the procedure.There was no adverse patient effect and there was no reported clinically significant delay in the procedure.No additional information is provided.

• Brand Name: ARMADA 18 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12374272
• Report Number: 2024168-2021-07575
• Device Sequence Number: 19916939
• Product Code: LIT
• UDI-Device Identifier: 08717648208188
• UDI-Public: 08717648208188
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151317
• 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): 08/26/2021

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: 06/30/2024
• Device Model Number: 1013468-060
• Device Catalogue Number: 1013468-060
• Device Lot Number: 1011241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR