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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 H7493926216300
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/20/2016
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.(b)(4).
 
Event Description
It was reported that foreign material was present on the wire lumen.The target lesion was located in a coronary artery.A 3.00x16 synergy¿ drug eluting stent was advanced to treat the lesion.However, resistance was encountered when the wire was inserted from the tip of the device and it failed to insert the wire.It was then noted there was foreign material on the wire lumen, about 4-5cm from the distal tip.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was good.
 
Manufacturer Narrative
Device evaluated by mfr.: the stent delivery system (sds); was returned for analysis.A visual examination of the crimped stent found no issues with the crimped stent.There were no signs of damage; stretching or lifting of the stent struts.The stent showed no signs of movement and was set equidistant between the proximal and distal markerbands.The bumper tip of the device showed signs of damage to the distal edge of the tip.This type of damage may have occurred during attempts to insert the guidewire through the tip.The balloon cone profiles were reviewed and no issues were noted with the overall balloon profile.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination found multiple kinks along the hypotube shaft.This type of damage is consistent with excessive force being applied to the delivery system and may have occurred during advancement attempts to the lesion site.A visual and tactile examination found severe damage to the inner lumen which was stretched and twisted at approximately 5mm distal from the bi-component bond and 4.5cm proximal from the bumper tip.Contrast media and blood was evident at this location but no foreign matter was detected.An attempt was made to insert a 0.014¿ guidewire through the port entry point however it could not move past the damage noted on the inner.This type of damage is consistent with excessive tensile force being applied to the delivery system during attempts to remove the guidewire from the device.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 root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).
 
Event Description
It was reported that foreign material was present on the wire lumen.The target lesion was located in a coronary artery.A 3.00x16 synergy¿ drug eluting stent was advanced to treat the lesion.However, resistance was encountered when the wire was inserted from the tip of the device and it failed to insert the wire.It was then noted there was foreign material on the wire lumen, about 4-5cm from the distal tip.The procedure was completed with another of the same device.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
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key5439151
MDR Text Key38284375
Report Number2134265-2016-00565
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,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/20/2016
Device Model NumberH7493926216300
Device Catalogue Number39262-1630
Device Lot Number18233388
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/25/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/24/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/16/2015
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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