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

Catalog Number	F2015-020
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Evaluation summary: visual and functional inspection was performed on the returned device.The reported leak was confirmed to be due to a cracked sidearm.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 from this lot.The investigation determined the reported leak to be due to the cracked sidearm; however, the cause of the crack could not be determined.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
Event or Problem Description
It was reported that during a peripheral procedure, the 1.5 x 20 mm armada 14 dilatation catheter was advanced to the target lesion in the anterior tibial artery.During the first inflation, fluid was leaking out of a small hole in the hub.The armada 14 was able to fully inflate and deflate, and dilatation was completed using the device.There was no adverse patient effect and no clinically significant delay.No additional information was provided.

• Brand Name: ARMADA 14 XT 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: 6719699
• Report Number: 2024168-2017-05946
• Device Sequence Number: 10933950
• Product Code: LIT
• UDI-Device Identifier: 08717648182884
• UDI-Public: 08717648182884
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K102705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2017

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: 02/29/2020
• Device Catalogue Number: F2015-020
• Device Lot Number: 70301G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2017
• Initial Report FDA Received Date: 07/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1