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

Lot Number	0030366613
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device sterility was compromised.A 2.25 x 16mm synergy xd drug-eluting stent was selected for treatment.During the preparation, the package inside the box was already partially opened, compromising the sterility of the complaint devices due to a visible tear or hole in the inner packages and the inner pouch not being intact.The procedure was completed another 2.25x16mm synergy xd device.No patient complications were reported.
Event or Problem Description
It was reported that the device sterility was compromised.A 2.25 x 16mm synergy xd drug-eluting stent was selected for treatment.During the preparation, the package inside the box was already partially opened, compromising the sterility of the complaint devices due to a visible tear or hole in the inner packages and the inner pouch not being intact.The procedure was completed another 2.25x16mm synergy xd device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: synergy xd mr us 2.25 x 16mm, was returned for analysis.A visual and tactile inspection of the packaging identified box packaging and inner pouch (with the device inside in its coiled hoop) was received with all the packaging opened.The closure strip was opened on the outer box and the inner pouch was torn open.An examination of the outer box noted a crease mark running down one side of the box and the corner of the box was frayed.No damage was noted to the inner pouch, apart from the fact that it had been opened.The device was removed from its protective hoop.A visual and tactile examination identified no kinks or damages along the entire length of the hypotube.A visual and tactile examination of the distal extrusion identified no damages.The stent protector was removed in order to inspect the balloon and crimped stent.No damages were observed to the balloon and stent.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19408878
• Report Number: 2124215-2024-31753
• Device Sequence Number: 12860371
• Product Code: NIQ
• UDI-Device Identifier: 08714729980728
• UDI-Public: 08714729980728
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/09/2024
• Device Lot Number: 0030366613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown