MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT

Model Number H7493926008350

Device Problem Break (1069)

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

Event Date 08/26/2020

Event Type  malfunction  

Event Description

During a left heart catheterization, the boston scientific stent was inserted into the guide catheter.Staff reported the stent snapped in half during the insertion.The broken stent shaft had not been inserted into the body yet and was easily pulled back out of the guide catheter.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10592597
• MDR Text Key: 208749062
• Report Number: 10592597
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H7493926008350
• Device Catalogue Number: H7493926008350
• Device Lot Number: 24997784
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/23/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24820 DA