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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION SYNERGY MEGATRON; CORONARY DRUG-ELUTING STENT Back to Search Results
Device Problems Break (1069); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/31/2021
Event Type  malfunction  
Event Description
It was reported that the sheath was broken.A synergy megatron drug eluting balloon expandable stent guide sheath was broken.No patient complications were reported.
 
Manufacturer Narrative
H6: device codes: updated.
 
Event Description
It was reported that the sheath was broken.A synergy megatron drug eluting balloon expandable stent guide sheath was broken.No patient complications were reported.It further reported that the device was not a synergy megatron device.It was non boston scientific device that malfunctioned and it was confirmed that there was no allegation against the synergy megatron device.
 
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Brand Name
SYNERGY MEGATRON
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key12528153
MDR Text Key273202876
Report Number2134265-2021-12076
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 09/30/2021
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
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/16/2021
Initial Date FDA Received09/24/2021
Supplement Dates Manufacturer Received09/28/2021
Supplement Dates FDA Received09/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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