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

Catalog Number 106553-001

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2017

Event Type  malfunction  

Event Description

An angiojet catheter was advanced into the vessel and error in system stated that saline flush was not running.The catheter was removed and re-prepped, but same error occurred.No harm to the patient - new angiojet catheter was opened and the case continued.

• Brand Name: ANGIOJET SPIROFLEX
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 47215 lakeview boulevard; fremont CA 94538
• MDR Report Key: 7024374
• MDR Text Key: 92192801
• Report Number: 7024374
• Device Sequence Number: 1
• Product Code: MCX
• 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: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Catalogue Number: 106553-001
• Device Lot Number: 20320905
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 39 YR