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

Model Number H7493941820350

Device Problem Unsealed Device Packaging (1444)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: used the first date of the month of the aware date as no event date was provided.

Event Description

It was reported that the seal packaging was compromised.A 3.50 x 20mm synergy xd was selected for use; however, it was noticed that the seal was broken.No patient complications were reported.

Event Description

It was reported that the seal packaging was compromised.A 3.50 x 20mm synergy xd was selected for use; however, it was noticed that the seal was broken.No patient complications were reported.

Manufacturer Narrative

(b3) date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr.: the carton was not returned for analysis and is not expected to be returned.A photo was provided showing a lifted blue seal at the top of a shelf carton.H3 other text : photo.

• Brand Name: SYNERGY XD
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11240370
• MDR Text Key: 229097601
• Report Number: 2134265-2021-00710
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729981053
• UDI-Public: 08714729981053
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2022
• Device Model Number: H7493941820350
• Device Lot Number: 0026088524
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1