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

Catalog Number	B1060-020
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/30/2016
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 customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a lesion with no tortuosity and 70% stenosis in the proximal superficial femoral artery.The armada 35 balloon catheter was prepped outside the anatomy prior to use using 50/50 contrast mix.The armada 35 was advanced to the target lesion and after inflation it was difficult to deflate the balloon.After several attempts holding negative pressure for less than 20 seconds, the balloon deflated.The patient outcome was good.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis as it was retained by the hospital.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 was performed and 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.Without having the device to examine, the investigation was unable to determine a conclusive cause for the reported deflation difficulty.

• 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: 6070752
• Report Number: 2024168-2016-07461
• Device Sequence Number: 13627096
• Product Code: LIT
• UDI-Device Identifier: 08717648154683
• UDI-Public: (01)08717648154683(17)190831(10)60319G1
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2016

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: B1060-020
• Device Lot Number: 60319G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/01/2016
• Supplement Report FDA Received Date: 11/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1