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

Catalog Number 109681-001

Device Problems Failure to Prime (1492); Defective Component (2292); Device Displays Incorrect Message (2591)

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

Event Date 05/16/2017

Event Type  malfunction  

Event Description

Defective catheter: angiojet solent omni catheter wouldn't prime.Error message "connect saline supply." catheter never entered the body.Rep was notified and came in and stated there have been issues with this catheter and he will replace it.

• Brand Name: SOLENT OMNI
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 6684092
• MDR Text Key: 78980850
• Report Number: 6684092
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Catalogue Number: 109681-001
• Device Lot Number: 20458785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/06/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR