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

Catalog Number	B2080-020
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2017
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 inability to inflate when the device was pressurized.There was a leak visible in the sidearm due to a crack.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 moderately calcified, mildly tortuous, lesion in the iliac artery.The 8mm x 20mm armada 35 balloon dilatation catheter (bdc) was advanced in the patient anatomy without resistance.During inflation, the balloon only partially inflated to 2 atmospheres.The armada 35 bdc was deflated without issue and was removed from the patient anatomy.Another armada 35 bdc was used to complete the procedure.The patient is doing fine.There was no adverse patient effect and no clinically significant delay in the procedure.There was 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: 7100780
• Report Number: 2024168-2017-09530
• Device Sequence Number: 13826711
• Product Code: LIT
• UDI-Device Identifier: 08717648155420
• UDI-Public: 08717648155420
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/08/2017

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: 06/30/2020
• Device Catalogue Number: B2080-020
• Device Lot Number: 70117G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 12/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 78