MAUDE Adverse Event Report: ABBOTT VASCULAR (AV-TEMECULA-CT) ARMADA 35 PTA; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number B2060-080

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 03/06/2014

Event Type  malfunction  

Event Description

The armada pta catheter would not hold atm (atmospheric) pressure while inflated during case.Noticed a leak at the hub of the catheter.Was able to use the balloon as long as it was straight which prevented it from leaking too much.Packaging appeared intact.Unknown why device failed.Case completed without further incident.
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manufacturer response for armada 35 pta catheter, armada 35 pta catheter (per site reporter).
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manufacturer will provide return ship kit and new replacement device.

• Brand Name: ARMADA 35 PTA
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): ABBOTT VASCULAR (AV-TEMECULA-CT); 26531 ynez rd; mailing p.o. box 9018; temecula CA 92589 901
• MDR Report Key: 3730054
• MDR Text Key: 15112973
• Report Number: 3730054
• Device Sequence Number: 1
• Product Code: LOX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: B2060-080
• Device Lot Number: 30304G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/31/2014
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR