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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
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BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Model Number 10602
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Date 12/01/2018
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.Date of event: used the first date of the month of the aware date as no event date was provided.
 
Event Description
It was reported that incorrect content of the package was encountered.A 2.5 x 16 synergy drug-eluting stent was selected for use; however, when the box was opened, a 2.50 x 20 synergy drug-eluting stent was inside the box.The device was not used inside the patient.
 
Event Description
It was reported that incorrect content of the package was encountered.A 2.5 x 16 synergy drug-eluting stent was selected for use; however, when the box was opened, a 2.50 x 20 synergy drug-eluting stent was inside the box.The device was not used inside the patient.
 
Manufacturer Narrative
Device is a combination product.Date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr: a boston scientific outer packaging box was received with the blue tab seal broken and the box open.The box was labelled with the following information: synergy monorail 2.50 x 16 mm, lot 22595298 and upn h7493926016250.Inside the box there was a sealed unopened foil pouch (pouch does not match box details), per foil pouch labelling: synergy monorail 2.50 x 20 mm, lot 22595748, upn h7493926020250.No issues were noted with pouch, all labelling was legible.
 
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Brand Name
SYNERGY
Type of Device
BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8268249
MDR Text Key133783612
Report Number2134265-2018-65229
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729840091
UDI-Public08714729840091
Combination Product (y/n)N
PMA/PMN Number
P150003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/21/2020
Device Model Number10602
Device Catalogue Number10602
Device Lot Number0022595298
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2019
Date Manufacturer Received02/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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