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

Catalog Number H7493926012300

Device Problems Component Missing (2306); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 10/06/2016

Event Type  malfunction  

Event Description

When opening package of stent, when it was taken out of the hoop the stylet and the shaping tube was not there.This was never used on the patient it was noticed prior to being used.

• 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: 6333093
• MDR Text Key: 67545874
• Report Number: 6333093
• 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: 10/19/2016,10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/21/2017
• Device Catalogue Number: H7493926012300
• Device Lot Number: 19422671
• 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: 10/19/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2016
• 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