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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 Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 01/23/2019
Event Type  malfunction  
Manufacturer Narrative
Device is combination product.
 
Event Description
It was reported that foreign material was found on the device.A 2.50 x 16 synergy stent was selected for treatment.However, when the physician open the device there was a hair on it.The procedure was completed with another of the same device.No patient complications were reported.
 
Manufacturer Narrative
Device is combination product.Device evaluated by mfr.: the device was returned for analysis.Initial examination - pre device decontamination.The investigator was present as the complaint device was received at the decontamination lab.The investigator removed the packaging and device from the used medical device kit at receipt.An opened foil pouch was returned.The foil pouch had been returned in an opened state.The opened foil pouch was visually inspected for foreign material (fm) and none was found.An opened inner tyvek pouch was returned.The inner tyvek pouch had been returned in an opened state.A hoop containing the device was inside the received opened tyvek pouch.A red bloodlike substance was noted on the hoop.A fibre/hair like fm was visually identified sitting loosely on the hoop.Photos were taken.The fm was removed and placed in a jar by the investigator.When transferring the fm to the jar with a tweezers the fm was broken into 2 sections.The hoop was removed from the open tyvek pouch and the device was removed from the hoop.The stent protector and mandrel were found to be in place at the distal end of the device.The device, opened tyvek pouch and hoop inspected for any other fm and no further fm was found.The device was deconned with a disinfectant foam and transferred to the evaluation lab with all returned packaging.Examination - post device decontamination.Synergy ous mr 4.00 x 38mm stent delivery system was in an opened foil pouch, opened tyvek pouch and hoop.The fm appeared to have a fibre/hair like shape and was black in colour.The length of the fm was measure, the total length of the fm (2 sections) was measured and the result was approximately 45mm.The measurement approximate due to curved shape of fm.Note the fm which was originally in one piece had been broken in 2 sections by the investigator.The fm was placed back into a jar and transferred to the bsc galway material characterisation lab for material analysis.Material analysis of the fm sample determined that it appeared to be a fibre of hair, both visually and through the ftir spectra.The foil pouch had been returned in an opened state.No damage was noted to the foil pouch (except the tear along the seal).The inner tyvek pouch had been returned in an opened state.No damage was noted to the tyvek pouch (except that the seal had been opened).A visual and microscopic examination of the crimped stent found no issues.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal marker bands.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 tactile examination of the hypotube found no issues.A visual and tactile examination of shaft polymer extrusion revealed no issues.A visual and microscopic examination found no damage to the tip.No other issues were noted during analysis.
 
Event Description
It was reported that foreign material was found on the device.A 2.50 x 16 synergy stent was selected for treatment.However, when the physician open the device there was a hair on it.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
BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8333530
MDR Text Key136008454
Report Number2134265-2019-01181
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729840091
UDI-Public08714729840091
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 03/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/09/2019
Device Model Number10602
Device Catalogue Number10602
Device Lot Number0022038798
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/14/2019
Date Manufacturer Received03/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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