MAUDE Adverse Event Report: BOSTON SCIENTIFIC ANGIOJET ZELANTEDVT THROMBECTOMY SET; ANGIOJET ZELANTEDVT THROMECTOMY SET

Model Number 114610-001

Device Problem Failure to Prime (1492)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/04/2017

Event Type  malfunction  

Event Description

The device would not prime prior to using on the patient.

• Brand Name: ANGIOJET ZELANTEDVT THROMBECTOMY SET
• Type of Device: ANGIOJET ZELANTEDVT THROMECTOMY SET
• Manufacturer (Section D): BOSTON SCIENTIFIC ; marlbourough ME 01752
• MDR Report Key: 6485564
• MDR Text Key: 72782603
• Report Number: MW5069029
• Device Sequence Number: 1
• Product Code: MCX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/10/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: 114610-001
• Device Lot Number: 20196112
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32 YR