MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	B1030-020
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis and reported leaking was unable to be confirmed.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.The complaint database was queried and found no similar events for leaking from this lot.Further assessment was performed which identified a potential product deficiency related to the manufacture of the device.The issue will be addressed per internal operating procedures.Av will continue to trend the performance of these devices.
Event or Problem Description
It was reported that the procedure was to treat an arteriovenous (av) fistula.It was noted that a 3x20mm armada 35 was leaking at the hub during the first attempted inflation.Another armda 35 was used to successfully complete the procedure.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

• Brand Name: ARMADA 35 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: 7172188
• Report Number: 2024168-2018-00152
• Device Sequence Number: 16482592
• Product Code: LIT
• UDI-Device Identifier: 08717648154485
• UDI-Public: 08717648154485
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K111899
• 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): 01/08/2018

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: 10/31/2019
• Device Catalogue Number: B1030-020
• Device Lot Number: 60505G2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 01/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1