MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET SOLENT PROXI; CATHETER, EMBOLECTOMY

Model Number 109676-001

Device Problems Device Alarm System (1012); Failure to Prime (1492)

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

Event Date 05/01/2020

Event Type  No Answer Provided  

Event Description

We tried to prime the catheter.It would get a few pumps in then give a error of catheter needs to be replaced.

• Brand Name: ANGIOJET SOLENT PROXI
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10082388
• MDR Text Key: 191812498
• Report Number: 10082388
• Device Sequence Number: 1
• Product Code: DXE
• 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: 05/20/2020

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?: No
• Device Operator: No Information
• Device Model Number: 109676-001
• Device Catalogue Number: 109676-001
• Device Lot Number: 24048788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/20/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1