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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY¿; CORONARY DRUG-ELUTING STENT
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BOSTON SCIENTIFIC - GALWAY SYNERGY¿; CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number H7493926238350
Device Problems Stretched (1601); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 09/13/2016
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.Device is a combination product.(b)(4).
 
Event Description
It was reported that stent damage occurred.During preparation of a 3.50 x 38 synergy drug - eluting stent (des), resistance was felt as the protector sheath was being removed.It was then noted that a part of the stent was stretched.The device was not used and the procedure was completed with a non-bsc stent.No patient complications were reported and the patient's status was good.
 
Manufacturer Narrative
Updated: device evaluated by mfr., eval summary attached, method codes, result codes and conclusion codes.Device evaluated by mfr: the stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent found that stent had detached from the delivery system and was damaged along its entire length.Stent struts were stretched and distorted.The maximum stent profile is within the specification.The stent protector was not returned for analysis.Based on the specified stent protector profile and the recorded crimped stent profile, there is no issues to note with the interaction between the two components.The balloon body was reviewed and no issues were noted with the overall balloon.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.The bumper tip of the device showed no signs of damage.A visual and tactile examination found no kinks along the full catheter length.A visual and tactile examination of the outer and mid-shaft section found no issues with the shaft polymer extrusion profile.The bi-component bond showed no signs of damage or strain.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).
 
Event Description
It was reported that stent damage occurred.During preparation of a 3.50 x 38 synergy drug - eluting stent (des), resistance was felt as the protector sheath was being removed.It was then noted that a part of the stent was stretched.The device was not used and the procedure was completed with a non-bsc stent.No patient complications were reported and the patient's status was good.
 
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Brand Name
SYNERGY¿
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6012910
MDR Text Key56931437
Report Number2134265-2016-08817
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
PMA/PMN Number
SIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/02/2017
Device Model NumberH7493926238350
Device Catalogue Number39262-3835
Device Lot Number18619236
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/20/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received11/28/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/23/2015
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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