MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REBEL; STENT, CORONARY

Model Number H7493927412400

Device Problem Device Slipped (1584)

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

Event Date 02/08/2019

Event Type  malfunction  

Event Description

Prepping the bare metal stent to be inserted into patient, and tech pulled stylet from the stent.The stent pulled off with the stylet.Manufacturer response for rebel stent, boston scientific (per site reporter).Will come by and pick it up and do test on the device.

• Brand Name: REBEL
• Type of Device: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8412031
• MDR Text Key: 138535339
• Report Number: 8412031
• Device Sequence Number: 1
• Product Code: MAF
• 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: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H7493927412400
• Device Catalogue Number: H7493927412400
• Device Lot Number: 23098108
• 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: 03/05/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20805 DA