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

Catalog Number	B2070-150
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Internal file number - (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 inability to maintain pressure, reported as failure to inflate.When the device was pressurized fluid was visible leaking from a crack in the side arm.A review of the complaint handling database found no similar incidents from this lot reported for cracks in the side arm.Av reviewed the lot history record and there were no manufacturing nonconformities that would have contributed to this complaint.Av conducted 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 lesion in the non-tortuous, mildly calcified, 80% stenosed, proximal to mid superficial femoral artery (sfa).A 7.0 x 150 mm armada 35 percutaneous transluminal angioplasty (pta) catheter was selected for the procedure.The pta catheter was advanced to the lesion and would not inflate.The pta catheter was removed from the anatomy and replaced with a new 7.0 x 100 mm armada 35 pta catheter to successfully complete the procedure.The physician speculated that the luer lock connector on the hub may have a crack, although no crack was observed.There was no reported clinically significant delay in the procedure.There was no reported adverse patient sequela.No additional information 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: 7248727
• Report Number: 2024168-2018-00886
• Device Sequence Number: 1090581
• Product Code: LIT
• UDI-Device Identifier: 08717648155406
• UDI-Public: 08717648155406
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/07/2018

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: 12/31/2019
• Device Catalogue Number: B2070-150
• Device Lot Number: 60719G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 02/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1