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

Catalog Number	B2040-150
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/14/2016
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 device was received.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 a 4.0 x 150 mm armada 35 percutaneous transluminal angioplasty (pta) catheter was selected for the procedure.The preparation of the pta catheter for use could not be completed due to the device leaking.The device was not used in the procedure.There was no patient involvement.There was no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).The device was returned for analysis and abbott vascular (av) confirmed the reported leak at the distal end of the hub.A review of the complaint handling database found no similar incidents from this lot.Av performed an expanded investigation and a product issue related to leakage at the hub was identified.It was determined that the root cause of the event was potentially related to hub assembly during manufacturing and corrective and preventative actions were implemented.The performance of these devices will continue to be monitored.

• 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: 6302580
• Report Number: 2024168-2017-00929
• Device Sequence Number: 16427472
• Product Code: LIT
• UDI-Device Identifier: 08717648155130
• UDI-Public: (01)08717648155130(17)181130(10)50624G1
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup
• Report Date (Section B): 02/22/2017

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: 11/30/2018
• Device Catalogue Number: B2040-150
• Device Lot Number: 50624G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/24/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/12/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2017
• Supplement Report FDA Received Date: 02/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1