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

Catalog Number	1013468-100
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/07/2017
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.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 air aspiration was being performed on the armada 18 dilatation catheter prior to use and air kept being aspirated out as if there was a hole in the device.This was performed four times with the same result.This device was not used on the patient.Another armada 18 was used to complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Evaluation summary: abbott vascular (av) analyzed the returned device and confirmed the reported difficulty performing air aspiration and identified that there was a leak at the distal end of the hub.A review of the complaint handling database found no similar incidents from this lot.Av reviewed the lot history record and there were no manufacturing nonconformities that would have contributed to this complaint.Av determined the most probable root cause is variability in the gluing process during manufacturing.The issue will be addressed per internal operating procedures.Av will continue to trend the performance of these devices.

• 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: 6446986
• Report Number: 2024168-2017-02674
• Device Sequence Number: 10878222
• Product Code: LIT
• UDI-Device Identifier: 08717648208201
• UDI-Public: (01)08717648208201(17)191231(10)6072941
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 05/11/2017

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: 12/31/2019
• Device Catalogue Number: 1013468-100
• Device Lot Number: 6072941
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/15/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/07/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2017
• Supplement Report FDA Received Date: 05/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1