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

Model Number	H7493941838220
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2022.It was reported that packaging damage occurred.A 2.25 x 38mm synergy drug eluting stent was selected for use.However, device was found on shelf with box crushed, packaging damaged, and broken seal.The inner package appeared intact but not sure if the device was compromised inside packaging due to outside damage.Sterility did not appear compromised.No patient complications reported.However, returned device analysis revealed seal compromised.
Additional Manufacturer Narrative
Device evaluation by mfr: the synergy xd mr 2.25 x 38mm stent delivery system (sds) was returned for analysis.Carton label details was examined and revealed blue tab broken, damage and tearing to bottom left corner of box, creasing to back of box, tearing on label, upper left corner damaged, dfu present, and patient info guide present.Pouch label details was examined and revealed inner pouch opened and label ripped.No other issues were identified during the product analysis.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15885946
• Report Number: 2124215-2022-47985
• Device Sequence Number: 5071938
• Product Code: NIQ
• UDI-Device Identifier: 08714729980773
• UDI-Public: 08714729980773
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2022

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
• Operator of Device: Other
• Device Expiration Date: 05/03/2024
• Device Model Number: H7493941838220
• Device Lot Number: 0029379886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2022
• 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