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

Model Number	B2060-150
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Internal file number - (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 during an intervention in the superficial femoral artery, during the first inflation, fluid was noted leaking at the hub of the armada 35 and it would not hold pressure.The device was removed and replaced with another armada 35 without further incident.There were no adverse patient effects 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.A search of the complaint handling database was performed and there were no other complaints identified from this lot related to hub leaking issues.A search of the lot history record for this specific lot indicated no related non-conformance records.Based on an expanded investigation, a product issue related to leakage at the hub was identified.It was determined that the root cause of the event was related to the hub assembly method used during manufacturing.Corrective and preventive actions were implemented and demonstrated to be effective.Abbott vascular will continue to trend the performance of these devices.

• 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: 6594079
• Report Number: 2024168-2017-04543
• Device Sequence Number: 19019293
• Product Code: LIT
• UDI-Device Identifier: 08717648155314
• UDI-Public: (01)08717648155314(17)180831(10)50325G1
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/12/2017

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: 08/31/2018
• Device Model Number: B2060-150
• Device Catalogue Number: B2060-150
• Device Lot Number: 50325G1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/05/2017
• Supplement Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 05/26/2017
• Supplement Report FDA Received Date: 09/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1