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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 26605
Device Problem Entrapment of Device (1212)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/09/2019
Event Type  malfunction  
Event Description
It was reported that a catheter and guidewire entrapment occurred.After a 300 es j choice guidewire crossed the lesion, a 10.0-31 carotid wallstent was advanced for treatment.However, when the stent was attempted to be released, it was noted that the guidewire stuck within the stent system and could not be released.The wallstent delivery system and the choice guidewire were removed together and the procedure was completed with another wallstent and another guidewire.There were no patient complications nor injuries reported and the patient's condition was stable.
 
Manufacturer Narrative
Device evaluated by mfr.: the device was returned loaded on to the customer's guidewire.During product analysis the customer's guidewire was found to be frozen inside the guidewire lumen of the returned device.A microscopic examination identified a blockage at the guidewire port of the device.For investigation purposes the investigator dissected the outer shaft of the device slightly to facilitate the removal of the customer's guidewire.A microscopic examination identified that the polymer coating of the customer's guidewire was damaged, peeling and bunched up at more than one location.It is unknown what could have caused this to happen.Although the outer shaft had been dissected slightly the investigator was able to successfully insert a new boston scientific 0.014" filterwire through this device with no resistance or issues experienced.A visual and tactile examination identified no issues with the catheter or delivery system that could potentially have contributed to the complaint incident.The device was returned with the stent fully mounted in the correct place on the device.No issues were identified with the returned device during the product analysis.
 
Event Description
It was reported that a catheter and guidewire entrapment occurred.After a 300 es j choice guidewire crossed the lesion, a 10.0-31 carotid wallstent was advanced for treatment.However, when the stent was attempted to be released, it was noted that the guidewire stuck within the stent system and could not be released.The wallstent delivery system and the choice guidewire were removed together and the procedure was completed with another wallstent and another guidewire.There were no patient complications nor injuries reported and the patient's condition was stable.
 
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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 Key9291575
MDR Text Key170118440
Report Number2134265-2019-13475
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,foreig
Type of Report Initial,Followup
Report Date 03/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/01/2019
Device Model Number26605
Device Catalogue Number26605
Device Lot Number0019322124
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2020
Initial Date Manufacturer Received 10/18/2019
Initial Date FDA Received11/07/2019
Supplement Dates Manufacturer Received03/05/2020
Supplement Dates FDA Received03/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GUIDE WIRE: CHOICE GUIDE WIRE; GUIDE WIRE: CHOICE GUIDE WIRE
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