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

Catalog Number	A2040-200
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.Based on the information provided, the reported balloon rupture appears to be due to operational circumstances of the procedure.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other similar incidents.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The additional device referenced is filed under a separate medwatch report.
Event or Problem Description
It was reported that the patient underwent a peripheral procedure to treat a target lesion in the heavily calcified right superficial femoral artery.The 4.0 x 120 mm armada 14 dilatation catheter was advanced to the target lesion.An attempt was made to inflate the balloon; however, on the first inflation, the balloon ruptured at 10 atmospheres (atm), possibly due to the vessel calcification.The device was removed without difficulty.The 6.0 x 20 mm armada 18 dilatation catheter was then advanced to the target lesion.This device was inflated to 10 atm and a rupture occurred at 10 atm, possibly due to the vessel calcification.The device was removed without difficulty.A non-abbott dilatation catheter was used.There was no adverse patient effect and no clinically significant delay.No additional information was provided.

• 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: 6024579
• Report Number: 2024168-2016-06893
• Device Sequence Number: 10972934
• Product Code: LIT
• UDI-Device Identifier: 08717648156175
• UDI-Public: (01)08717648156175(17)190630(10)6010741
• 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): 10/12/2016

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: 06/30/2019
• Device Catalogue Number: A2040-200
• Device Lot Number: 6010741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2016
• Initial Report FDA Received Date: 10/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 83