MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MONORAIL CORONARY STENT SYSTEM - EXPRESS SD RENAL/BILIARY; STENT, RENAL

Model Number H74937912618150

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 09/26/2018

Event Type  malfunction  

Event Description

While performing a right leg angiography and during the procedure, the balloon mounted stent deployed and became disconnected.Due to this premature deployment, the surgeon needed to take the patient from interventional radiology to the or for a right femoral cut down to retrieve the stent.

• Brand Name: MONORAIL CORONARY STENT SYSTEM - EXPRESS SD RENAL/BILIARY
• Type of Device: STENT, RENAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7990292
• MDR Text Key: 124546386
• Report Number: 7990292
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H74937912618150
• Device Catalogue Number: H74937912618150
• Device Lot Number: 21842142
• 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: 10/10/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21170 DA