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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
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BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Model Number H7493926024220
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.(b)(4).
 
Event Description
It was reported the package seal was compromised.A 2.25 x 24mm synergy ii drug-eluting stent was selected.When the package was received, it was noted that the package was damaged.The product box was damaged and to make sure that the packaging inside was not opened or anything, they took the box off.It was noted that the beads in the stent which looked like "moisture leakers" burst open and it was spilled in the sterile package and caused tiny holes in the sterile package.The device was not used in the patient.No patient complications were reported.
 
Manufacturer Narrative
Device lot number, device expiration date, device evaluated by mfr.Device evaluated by mfr.: a synergy ii us 2.25x24mm outer box was returned with the foil pouch and inner pouch for analysis.The back of the returned outer box was damaged with the seal torn and the outer box opened.Minor damage was also noted on the side of the outer box.All labelling information was fully legible.The inner foil pouch seal was intact.Small bumps could be seen on the foil pouch.The foil pouch was then opened by the quality technician to examine the inner packaging.Inside the foil pouch the strippax sorbent pouch was opened and the beads from the pouch had spilled into the foil pouch.Dye was poured into the foil pouch to confirm no leak was caused by the small bumps caused by the strippax beads.No leak was present in the foil pouch indicating the sterility of the product was not compromised.The inner pouch seal was intact and it had not been opened.No other issues were identified during the product analysis.The investigation conclusion is manufacturing execution error as the manufacturing process was not executed as validated/as designed.(b)(4).
 
Event Description
It was reported the package seal was compromised.A 2.25 x 24mm synergy ii drug-eluting stent was selected.When the package was received, it was noted that the package was damaged.The product box was damaged and to make sure that the packaging inside was not opened or anything, they took the box off.It was noted that the beads in the stent which looked like "moisture leakers" burst open and it was spilled in the sterile package and caused tiny holes in the sterile package.The device was not used in the patient.No patient complications were reported.
 
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Brand Name
SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
Type of Device
BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7296123
MDR Text Key101128059
Report Number2134265-2018-01208
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P150003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 02/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2018
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2018
Device Model NumberH7493926024220
Device Catalogue Number39260-2422
Device Lot Number21474767
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/19/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/30/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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