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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 Problems Entrapment of Device (1212); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/09/2020
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.(b)(6).
 
Event Description
It was reported that entrapment on guidewire occurred.The target lesion was located in the internal carotid artery.A 10.0-31 carotid wallstent was selected for use.During the procedure, there was difficulty advancing the stent over the guidewire.The stent became stuck on the wire and both were removed from the patient.The procedure was completed with another of the same guidewire and stent.There were no patient complications and the patient was fine.
 
Manufacturer Narrative
A2: age at time of event: (b)(6).E1: initial reporter phone: (b)(6).Device evaluated by mfr: the device was returned loaded on to the customer guidewire.The device was covered in a red blood like substance.The outer diameter of the guidewire used by the customer was confirmed to measure 0.0135 inch using a snap gauge.During product analysis the customer 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.The customer guidewire was removed.A microscopic examination identified that the polymer coating of the customer guidewire was damaged, peeling and bunched up at more than one location.It is unknown what could have caused this to happen.A new boston scientific 0.014 inch filterwire was successfully inserted 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.
 
Event Description
It was reported that entrapment on guidewire occurred.The target lesion was located in the internal carotid artery.A 10.0-31 carotid wallstent was selected for use.During the procedure, there was difficulty advancing the stent over the guidewire.The stent became stuck on the wire and both were removed from the patient.The procedure was completed with another of the same guidewire and stent.There were no patient complications and the patient was fine.
 
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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 Key9990640
MDR Text Key188886986
Report Number2134265-2020-05467
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 06/12/2020
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 Date05/14/2023
Device Model Number26605
Device Catalogue Number26605
Device Lot Number0024763098
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/28/2020
Initial Date Manufacturer Received 04/09/2020
Initial Date FDA Received04/23/2020
Supplement Dates Manufacturer Received05/26/2020
Supplement Dates FDA Received06/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GUIDEWIRE: 0.014 INCH ALLSTAR WIRE; GUIDEWIRE: 0.014 INCH ALLSTAR WIRE
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