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

Model Number	H7493941832300
Medical Device Problem Codes	Contamination (1120); Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via user/facility medwatch# (b)(4) that device contamination occurred.A 3.00 x 32mm synergy xd drug-eluting stent was selected for use.However, during the opening of the package it was not ripped down the one side all the way.The device was caught in the packaging and the stent was dropped and contaminated.The procedure was completed with another stent.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 3.00 x 32mm stent delivery system (sds) was returned for analysis.The synergy xd device was received inside the shelf carton.Apart from the fact that the blue closure strip on the box shelf carton had been opened, there was no visible damage to the carton.Inside the shelf carton was the device in its torn pouch.The pouch was received torn open.The pouch was clearly labelled correctly with no damage observed to the labelling.Inside the pouch was the synergy xd 3.00/32 lot: 27857221-041, with attached pressure chart and directions for use card.An examination of the pouch confirmed that the pouch was torn open in a non uniform way.Part of the side seal was lifted (opened) and part remains stuck to seal.An examination of the synergy xd mr us 3.00 x 32mm stent delivery system (sds) identified no evidence of any device use.H6 device codes - difficult to open or remove packaging material has been added.
Event or Problem Description
It was reported via user/facility medwatch# (b)(4) that device contamination occurred.A 3.00 x 32mm synergy xd drug-eluting stent was selected for use.However, during the opening of the package it was not ripped down the one side all the way.The device was caught in the packaging and the stent was dropped and contaminated.The procedure was completed with another stent.There were no patient complications reported.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14379348
• Report Number: 2134265-2022-04677
• Device Sequence Number: 4874784
• Product Code: NIQ
• UDI-Device Identifier: 08714729981008
• UDI-Public: 08714729981008
• Combination Product (Y/N): Y
• Initial Reporter State: MT
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2022

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: Health Professional
• Device Expiration Date: 08/09/2023
• Device Model Number: H7493941832300
• Device Lot Number: 0027870456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 07/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2021
• 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