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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAROTID WALLSTENT; STENT, CAROTID
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BOSTON SCIENTIFIC CORPORATION CAROTID WALLSTENT; STENT, CAROTID Back to Search Results
Model Number 26606
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 04/04/2019
Event Type  malfunction  
Event Description
It was reported that a foreign material was found inside the packaging.During preparation, a 10.0-24 carotid wallstent was unpacked from the box.However, when the product packaging was tried to open, a 5mm wire-like foreign object was found inside the packaging.The device was not taken out from its packaging.Another 10.0-24 carotid wallstent was unpacked and completed the procedure.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: a visual and microscopic examination was performed on the returned device and packaging.The carotid device was returned within both the outer and inner tray packaging.Both the outer and inner packaging were fully sealed and undamaged.No issues were noted with the packaging.A visual and microscopic examination noted foreign material (fm) within the sealed packaging.The fm was noted to be black in colour and was clearly visible.In order to examine the fm further the outer packaging was opened, the fm was noted to be within the sealed inner packaging.The inner packaging was opened and the fm removed.A microscopic examination of the fm noted it to be solid, approximately 4mm in length and tapered and one end.On further review the fm appeared to be consistent with the packing mandrel.The investigator removed the carotid device from its protective hoop, the packing mandrel was noted to be severely kinked at the proximal end near the monorail exit port.Microscopic examination identified that the proximal end of the mandrel was also tapered and appeared dissected.The packing mandrel was removed from the device without any resistance noticed, the mandrel measured approximately 246mm in length.No stretching damage was noted on the mandrel.The investigator then microscopically examined both the fm and packing mandrel together.It was noted that both ends were tapered and when reviewed microscopically together, it was determined that the fm was a detached section of the packing mandrel.A visual and tactile examination of the device identified no damage or any issues with the catheter that could have contributed to the complaint incident.A visual and microscopic examination of the crimped stent identified no damage or any issues.No other issues were identified during the product analysis.
 
Event Description
It was reported that a foreign material was found inside the packaging.During preparation, a 10.0-24 carotid wallstent was unpacked from the box.However, when the product packaging was tried to open, a 5mm wire-like foreign object was found inside the packaging.The device was not taken out from its packaging.Another 10.0-24 carotid wallstent was unpacked and completed the procedure.No patient complications were reported.
 
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Brand Name
CAROTID WALLSTENT
Type of Device
STENT, CAROTID
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8540754
MDR Text Key142788592
Report Number2134265-2019-04208
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
PMA/PMN Number
P050019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 05/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/22/2022
Device Model Number26606
Device Catalogue Number26606
Device Lot Number0023218814
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/16/2019
Date Manufacturer Received05/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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