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

Catalog Number	1013468-100
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2017
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.Evaluation summary: the device was returned for analysis and abbott vascular (av) confirmed the reported leak when the device was pressurized.The leak was detected at the base of the strain relief tubing.The lot history record was reviewed and did not identify any non-conformities from this lot for leaks.A review of the complaint handling database found no similar incidents from this lot reported for leaks at the strain relief.Av conducted a thorough root cause analysis and determined the issue may be related to manufacturing.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 heavily calcified left popliteal artery.A 5.0 x 100mm armada balloon dilatation catheter (bdc) was used for pre-dilatation.The bdc was inflated once at 14 atmospheres and it was noted there was a leak at the hub.The physician continued to attempt to pressurize the balloon (which was inflated) but it would not hold the pressure.Another armada 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 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: 7061262
• Report Number: 2024168-2017-09179
• Device Sequence Number: 1932991
• Product Code: LIT
• UDI-Device Identifier: 08717648208201
• UDI-Public: 08717648208201
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/27/2017

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: 09/30/2020
• Device Catalogue Number: 1013468-100
• Device Lot Number: 7040541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 11/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1