MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET® SPIROFLEX®; CATHETER, CORONARY, ATHERECTOMY

Model Number 08714729889380

Device Problem Failure to Prime (1492)

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

Event Date 04/24/2019

Event Type  malfunction  

Event Description

The device was hooked to the system (anjiojet) and when it was primed (filling with solution to remove the air) it would not prime.The solution would not continue through to fill.Everything was disconnected and reconnected but still would not prime.So a new device was used, and worked fine.

• Brand Name: ANGIOJET® SPIROFLEX®
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 150 baytech drive; san jose CA 95134
• MDR Report Key: 8649195
• MDR Text Key: 146346922
• Report Number: 8649195
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/03/2019,04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 08714729889380
• Device Catalogue Number: 106553-001
• Device Lot Number: 23262292
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/03/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/29/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1