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

Model Number	A2030-200
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned to abbott vascular for analysis.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 reported from this lot.The device was prepped prior to use without any issue noted, which would suggest that the device was not damaged prior to use.The investigation determined the reported balloon rupture appears to be related to operational circumstances of the procedure.Based on the reported information, it is likely that during advancement through the heavily calcified chronic totally occluded lesion, the outer surface of the balloon became compromised and/or damaged resulting in a balloon rupture during inflation at 4 atmospheres.There is no indication of a product quality issue with respect to manufacture, design or labeling.The other armada, is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified chronic totally occluded lesion in the anterior tibial artery.Reportedly, a 3.0mm/120mm armada 14 percutaneous transluminal angioplasty (pta) balloon catheter was inflated once and ruptured at 6 atmospheres (atm).A 3.0mm/200mm armada 14 pta balloon catheter was inflated once and ruptured at 4 atm.The procedure was successfully completed with a smaller unspecified balloon dilatation catheter for pre-dilatation and laser atherectomy.There was no reported clinically significant delay in the procedure and no reported adverse patient effects.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: 10511934
• Report Number: 2024168-2020-07516
• Device Sequence Number: 3546156
• Product Code: DQY
• UDI-Device Identifier: 08717648156113
• UDI-Public: 08717648156113
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2020

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: 10/31/2023
• Device Model Number: A2030-200
• Device Catalogue Number: A2030-200
• Device Lot Number: 0050741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR