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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY XD; CORONARY DRUG-ELUTING STENT
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BOSTON SCIENTIFIC CORPORATION SYNERGY XD; CORONARY DRUG-ELUTING STENT Back to Search Results
Lot Number 0029181382
Device Problems Obstruction of Flow (2423); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/11/2023
Event Type  malfunction  
Event Description
It was reported that a foreign material was found on the device.A 2.75 x 24mm synergy xd drug-eluting stent was selected for use.However, during preparation, a foreign object was noted at the hub and due to this object, the inflation device could not be connected to the hub.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.
 
Event Description
It was reported that a foreign material was found on the device.A 2.75 x 24mm synergy xd drug-eluting stent was selected for use.However, during preparation, a foreign object was noted at the hub and due to this object, the inflation device could not be connected to the hub.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.
 
Manufacturer Narrative
Returned product consisted of a synergy xd drug eluting stent.A visual, tactile and microscopic examination of the returned device was performed.A detailed examination of the hub manifold identified that the manifold was plugged with a piece of plastic, consistent with the tip of a syringe.It was not possible to remove this from the hub.No damage was observed to actual hub.No damage was observed along the balloon.The stent was fully crimped onto the balloon.No other damage was observed along the device.
 
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Brand Name
SYNERGY XD
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 Key17424847
MDR Text Key320044451
Report Number2124215-2023-39933
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/28/2024
Device Lot Number0029181382
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/01/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/29/2022
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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