MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	1013469-040
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2017
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 to abbott vascular (av) for analysis.Av reviewed the lot history record and there were no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Av conducted root cause analysis and determined the issue may be related to a potential product quality issue.The issue is being 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 a lesion in the superficial femoral artery (sfa) with no tortuosity or calcification.The 5.5 x 40 mm armada 18 balloon dilatation catheter (bdc) was advanced without issue.The bdc began to be inflated in an attempt to go to nominal pressure, but a leak was observed at the hub.The inflation was stopped, and the device was removed without issue, and replaced.A new 5.5 x 40 mm armada 18 bdc was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: ARMADA 18 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: 7184763
• Report Number: 2024168-2018-00325
• Device Sequence Number: 16632174
• Product Code: LIT
• UDI-Device Identifier: 08717648208287
• UDI-Public: 08717648208287
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K151317
• 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): 01/11/2018

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: 09/30/2020
• Device Catalogue Number: 1013469-040
• Device Lot Number: 7040641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 01/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1