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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
Model Number H7493942828500
Device Problems Difficult to Remove (1528); Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/20/2022
Event Type  malfunction  
Event Description
It was reported that difficulties removing a balloon and balloon rupture occurred.A 5.00 x 28mm synergy megatron was deployed at the saphenous vein graft (svg).However, while deflating the balloon, issues removing the balloon from the stent occurred.The balloon was inflated, deflated, and pulled to negative.It was noted that at some point the balloon had ruptured as blood was noticed to have come back into the inflation device.The balloon was unable to be withdrawn.The device was removed together on the wire with a spider embolic device attached.The device was removed intact.It was noted that the stent appeared to be unaffected by this.Post dilatation was not performed.The procedure was completed.No patient complications were reported in relation to this event.
 
Manufacturer Narrative
Device evaluated by manufacturer: synergy megatron mr us 5.00 x 28mm): catheter was returned for analysis, the following attributes were examined: stent profile: no stent was returned as it was implanted without issues at the lesion site.Balloon profile: the balloon was reviewed, and it was found to be in a partially deflated state with blood like substance visible inside balloon cones.Tip profile: a visual and microscopic examination of the bumper tip showed no signs of tip damage.Hypotube profile: a visual and tactile examination of the hypotube found multiple kinks.Shaft polymer extrusion profile: a visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found the mid shaft section stretched 36cm proximal to distal tip.Functional analysis: the device was soaked for several days in a water and an inflation attempt was made where an inflation aid was attached to the manifold hub of the device.Balloon could be inflated, and no leaks or damages were noted with it however pressure could not be maintained in the inflation device due to leak noted at the exchange port.No other issues were identified during analysis.
 
Event Description
It was reported that difficulties removing a balloon and balloon rupture occurred.A 5.00 x 28mm synergy megatron was deployed at the saphenous vein graft (svg).However, while deflating the balloon, issues removing the balloon from the stent occurred.The balloon was inflated, deflated, and pulled to negative.It was noted that at some point the balloon had ruptured as blood was noticed to have come back into the inflation device.The balloon was unable to be withdrawn.The device was removed together on the wire with a spider embolic device attached.The device was removed intact.It was noted that the stent appeared to be unaffected by this.Post dilatation was not performed.The procedure was completed.No patient complications were reported in relation to this event.
 
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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
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 Key15002974
MDR Text Key304018474
Report Number2134265-2022-07543
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729985761
UDI-Public08714729985761
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 08/18/2022
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
Device Operator Health Professional
Device Expiration Date08/09/2022
Device Model NumberH7493942828500
Device Lot Number0027850191
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/20/2022
Initial Date FDA Received07/13/2022
Supplement Dates Manufacturer Received08/05/2022
Supplement Dates FDA Received08/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/09/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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