MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 14 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	A2030-060
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 incidents reported from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties and there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.The 3.0 x 20 mm armada 14 and the 4.0 x 20 mm armada 14 dilatation catheters referenced are filed under separate medwatch reports.
Event or Problem Description
It was reported that the patient underwent a peripheral artery procedure.The 3.0 x 60 mm armada 14 and the 3.0 x 20 mm armada 14 dilatation catheters were each advanced to the target lesion in the anterior tibial artery, without difficulty.Attempts were made to inflate the balloons; however, for each device, the balloon would not inflate.There was no adverse patient effect.The devices were able to be removed from the patient anatomy without difficulty and the target lesion was treated with an additional device.The 4.0 x 20 mm armada 14 dilatation catheter was advanced to the target lesion in the heavily calcified superficial femoral artery (sfa); however, during the second inflation, the balloon ruptured at 8 atmospheres (atm).The device was removed without issue and there was no adverse patient effect.A second device was used successfully to complete dilatation of the sfa.There was no additional information provided regarding the above mentioned devices.

• Brand Name: ARMADA 14 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6330966
• Report Number: 2024168-2017-01192
• Device Sequence Number: 1564519
• Product Code: LIT
• UDI-Device Identifier: 08717648156083
• UDI-Public: (01)08717648156083(17)190831(10)6030441
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/14/2017

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: 08/31/2019
• Device Catalogue Number: A2030-060
• Device Lot Number: 6030441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2017
• Initial Report FDA Received Date: 02/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR