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

Model Number	H7493941820300
Medical Device Problem Codes	Contamination (1120); Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that sterility was compromised.A 3.00 x 20mm synergy xd drug-eluting stent was selected for use.It was noted that the product was properly sealed in the box, but the sterile packaging on the inside the box was opened and seemed to be unsterile.
Additional Manufacturer Narrative
B3 date of event: used the first day of the month of bsc aware date since event date was not provided.
Event or Problem Description
It was reported that sterility was compromised.A 3.00 x 20mm synergy xd drug-eluting stent was selected for use.It was noted that the product was properly sealed in the box, but the sterile packaging on the inside the box was opened and seemed to be unsterile.
Additional Manufacturer Narrative
B3 date of event: used the first day of the month of bsc aware date since event date was not provided.Device evaluated by mfr: a 3.00 x 20mm synergy xd catheter was returned for analysis.A visual and microscopic analysis was performed on the returned device.Received was the device inside its box packaging.An examination of the outer box found that the blue closure strip was peeled open.The top corners of the outer box were creased and there was handwriting in black ink on the outside of the box.An examination of the inner pouch confirmed that the pouch had been torn open.The device was inside the pouch.An examination of the pouch found clear evidence of the pouch seals.The device was removed and examined.There was no evidence of any device use.No damages were observed along the entire length of the device.A microscopic examination of the inner pouch identified that although the pouch was torn open, there was clear evidence of the pouch seals.This confirms that the pouch was sealed.

• 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: 17373902
• Report Number: 2124215-2023-36869
• Device Sequence Number: 7009430
• Product Code: NIQ
• UDI-Device Identifier: 08714729980971
• UDI-Public: 08714729980971
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

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: 10/02/2024
• Device Model Number: H7493941820300
• Device Lot Number: 0030332764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2023
• Supplement Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2022
• 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