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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
Lot Number 0030025056
Device Problems Deflation Problem (1149); Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/30/2023
Event Type  malfunction  
Event Description
It was reported that difficult to remove a balloon occurred.A 5.00 x 20mm synergy megatron stent was selected for use.The stent was advanced to the target lesion and deployed.During withdrawing, the balloon did not fully deflate at its port level, and it was impossible to pass the balloon through the catheter for removal.The physician removed the guide guidewire, catheter and the stent balloon as one piece together.The procedure was completed successfully with this device.There were no patient complications reported.
 
Manufacturer Narrative
Device evaluated by manufacturer: a 5.00 x 20mm synergy megatron stent delivery system (sds) was returned to the complaint investigation site (cis).Visual, tactile, microscopic and functional analysis was performed on the device.There were no issues noted on the shaft.A guidewire and guide catheter were attached to the device and could not be removed.The shaft polymer extrusion visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.The guide catheter was folded in which made it impossible to remove the device.There was no stent attached to the device; the stent was correctly delivered within the patient.The balloon was subjected to positive pressure and was in a deflated state.Bumper tip showed no signs of distal tip damage.The device was attached to an encore inflation unit and the balloon was inflated.The device held pressure and had deflated in 13 seconds.The encore device was verified before and after use using the druck gauge to rbp 16 atmospheres as per instructions for use (ifu).Inspection of the remainder of the device presented no other damage or irregularities.
 
Event Description
It was reported that difficult to remove a balloon occurred.A 5.00 x 20mm synergy megatron stent was selected for use.The stent was advanced to the target lesion and deployed.During withdrawing, the balloon did not fully deflate at its port level, and it was impossible to pass the balloon through the catheter for removal.The physician removed the guide guidewire, catheter and the stent balloon as one piece together.The procedure was completed successfully with this device.There were no patient complications reported.
 
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Brand Name
SYNERGY MEGATRON
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key17277276
MDR Text Key318559702
Report Number2124215-2023-34972
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/22/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number0030025056
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/05/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/03/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/15/2022
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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