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

Catalog Number	1013470-080
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation determined that the reported balloon rupture appears to be related to circumstances of the procedure.The 5.5 x 100 mm armada 18 and 4.0 x 12 mm armada 14 are being filed under separate medwatch reports.
Event or Problem Description
It was reported the procedure was to treat a heavily calcified lesion in the superficial femoral artery (sfa).The 6.0 x 80 mm armada 18 was advanced to the target lesion, but ruptured at 8 atmosphere (atm) during the first inflation.A 5.5 x 100 mm armada 18 was advanced to the target lesion but ruptured at 8 atm during the first inflation as well.A 4.0 x 12 mm armada 14 was advanced to the target lesion; however, a rupture occurred at unknown pressure during the first inflation.Another new armada 14 was used to complete the procedure successfully.There was no adverse patient effect 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: 6080848
• Report Number: 2024168-2016-07640
• Device Sequence Number: 974558
• Product Code: LIT
• UDI-Device Identifier: 08717648208416
• UDI-Public: (01)08717648208416(17)190831(10)6032941
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 11/04/2016

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: 08/31/2019
• Device Catalogue Number: 1013470-080
• Device Lot Number: 6032941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2016
• Initial Report FDA Received Date: 11/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR