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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
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BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Model Number 10602
Device Problem Entrapment of Device (1212)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/01/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: used the 1st day of the month of the bsc aware date as no event date was provided.Device is a combination product.
 
Event Description
It was reported that catheter entrapment occurred.The target lesion was located in a coronary artery.A 3.00 x 16 synergy drug-eluting stent was advanced for treatment.However, it was noted that the stent could not be removed from the wire and had to pull everything out.The procedure was completed with another wire and stent.There were no patient complications reported and the patient was fine.
 
Event Description
It was reported that catheter entrapment occurred.The target lesion was located in a coronary artery.A 3.00 x 16 synergy drug-eluting stent was advanced for treatment.However, it was noted that the stent could not be removed from the wire and had to pull everything out.The procedure was completed with another wire and stent.There were no patient complications reported and the patient was fine.
 
Manufacturer Narrative
(b3) date of event: used the 1st day of the month of the bsc aware date as no event date was provided.Device evaluated by mfr.: synergy ii us mr 3.00 x 16mm stent delivery system was returned for analysis with a guidewire inserted into the exchange port, but not exiting at the tip, of the device.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The crimped stent outer diameter was measured using snap gauge and the result was within maximum crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip showed no issues.A visual and tactile examination of the hypotube found no issues.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.The device was returned with the floppy end of a guidewire stuck in the exchange port of the device.The device and attached guidewire was soaked in a bath at 37 degrees.Once removed from the bath the guidewire was removed without issue from the device and was able to be re-inserted through the distal tip and exited at the exchange port with no issues.The guidewire diameter was checked and the recorded diameter was below the maximum value.No issues were noted with the guidewire.No issues were identified during the product analysis.
 
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Brand Name
SYNERGY
Type of Device
BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10306033
MDR Text Key199856760
Report Number2134265-2020-09188
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729840114
UDI-Public08714729840114
Combination Product (y/n)N
PMA/PMN Number
P150003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/26/2022
Device Model Number10602
Device Catalogue Number10602
Device Lot Number0025167160
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2020
Date Manufacturer Received08/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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