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

Model Number H7493926038220

Device Problems Fracture (1260); Kinked (1339)

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

Event Date 07/19/2017

Event Type  malfunction  

Event Description

During prep of device, the delivery device was kinked and used.Stent delivery catheter fractured immediately after removal from the body.

• Brand Name: SYNERGY¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 5905 nathan lane; plymouth MN 55442
• MDR Report Key: 6770445
• MDR Text Key: 81944742
• Report Number: 6770445
• Device Sequence Number: 1
• Product Code: NIQ
• 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: 07/27/2017,08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Model Number: H7493926038220
• Device Catalogue Number: H7493926038220
• Device Lot Number: 19838864
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/27/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: A WIRE WAS BEING USED AS IT IS WITH ALL STENT DELI
• Patient Age: 71 YR
• Patient Weight: 83