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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT
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BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 10632
Device Problem Contamination (1120)
Patient Problem No Patient Involvement (2645)
Event Date 04/11/2019
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that the sterility was compromised.During unpacking of a 2.50x48mm synergy ii drug-eluting stent, it was noted that the device was unsterile.The procedure was completed with another of the same device.No patient complications were reported.
 
Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ous mr 2.50 x 48mm stent delivery system was returned for analysis.Pre-decontamination analysis revealed no evidence of foreign material (fm) on the device.The device was inspected visually and via a scope to inspect for fm.No defects were noted.However, a red blood like substance was noted on the balloon cones.No packaging was returned.When drying the device post decontamination, the stent was accidently caught on the wipe due to handling error causing some stent damage.Visual and microscopic examination of the crimped stent identified stent damage, damage was noted to the 2 most proximal stent strut rows with stent strut lifted and pulled distally.The undamaged crimped stent od (outer diameter) was measured and the result was within max crimped stent profile measurement.The balloon was reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Visual and tactile examination of the hypotube found no issues.Visual and tactile examination of the shaft polymer extrusion found no issues.Visual and microscopic examination found no issues with the tip.No foreign material was present on the device.No other issues were identified during the product analysis.
 
Event Description
It was reported that the sterility was compromised.During unpacking of a 2.50x48mm synergy ii drug-eluting stent, it was noted that the device was unsterile.The procedure was completed with another of the same device.No patient complications were reported.
 
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Brand Name
SYNERGY
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8575412
MDR Text Key143943914
Report Number2134265-2019-04734
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/04/2020
Device Model Number10632
Device Catalogue Number10632
Device Lot Number0023325125
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/22/2019
Date Manufacturer Received06/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age49 YR
Patient Weight75
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