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

Model Number H7493941832300

Device Problems Difficult to Open or Remove Packaging Material (2922); Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/28/2022

Event Type  malfunction  

Event Description

Package that the stent comes in usually rips open a certain way.When this stent package was opened it didn't rip down the one side all the way and got caught in the packaging and the stent was dropped and got contaminated.

• Brand Name: SYNERGY¿ XD
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlbourogh MA 01752
• MDR Report Key: 14140931
• MDR Text Key: 289494108
• Report Number: 14140931
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/31/2022,03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H7493941832300
• Device Catalogue Number: H7493941832300
• Device Lot Number: 27870456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/31/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1