Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAROTID WALLSTENT; STENT, CAROTID
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION CAROTID WALLSTENT; STENT, CAROTID Back to Search Results
Model Number 26605
Device Problem Difficult to Insert (1316)
Patient Problems Vasoconstriction (2126); Patient Problem/Medical Problem (2688)
Event Date 04/22/2019
Event Type  Injury  
Event Description
It was reported that vasospasm occurred.A.014 guidewire was selected for used together with the filterwire and a carotid wallstent for a stenting procedure.The carotid wallstent was inserted onto the filterwire and the guidewire.The guidewire reach the junction of the carotid artery stent but after several attempts the guidewire could not advance.Angiography was performed and the patient experienced vasospasm.The stent was then removed due to the guidewire advancement restriction.Subsequently, the filterwire was removed then the angiography was performed again.The.014 guidewire was put in place, and the 7x40 stent was opened, however; the.014 guidewire still could not cross the stent.Another device was used to complete the procedure.No further patient complications were reported.
 
Event Description
It was reported that vasospasm occurred.A.014 guidewire was selected for used together with the filterwire and a carotid wallstent for a stenting procedure.The carotid wallstent was inserted onto the filterwire and the guidewire.The guidewire reach the junction of the carotid artery stent but after several attempts the guidewire could not advance.Angiography was performed and the patient experienced vasospasm.The stent was then removed due to the guidewire advancement restriction.Subsequently, the filterwire was removed then the angiography was performed again.The.014 guidewire was put in place, and the 7x40 stent was opened, however; the.014 guidewire still could not cross the stent.Another device was used to complete the procedure.No further patient complications were reported.It was further reported that the guidewire used was not a bsc device.
 
Manufacturer Narrative
Device evaluated by mfr.: the device was returned with the stent fully mounted onto the delivery system.The customer's guidewire was not returned for analysis.A visual and tactile examination identified no damage along the length of the catheter.This carotid device is recommended for use with a 0.014" guidewire.A boston scientific 0.014" test guidewire was selected and it was attempted to load the device onto the guidewire.The guidewire was noted to meet severe resistance approximately 1mm proximal to the monorail exit port.This resistance prevented the guidewire from passing through the monorail exit port.A visual and microscopic examination of the catheter noted that the inner shaft and outer sheath were slightly misaligned with each which resulted in the resistance during guidewire insertions.The investigator manipulated the catheter and realigned the inner and outer shafts and successfully inserted the guidewire through the device and out the monorail exit port.No issues were noted with the catheter that could have contributed to the complaint incident.A visual and microscopic examination identified no damage or any issues with the stent or tip of the device that could have contributed to the complaint incident.No other issues were identified during the product analysis.Patient codes corrected from 2688 to 2126.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CAROTID WALLSTENT
Type of Device
STENT, CAROTID
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8628200
MDR Text Key145651451
Report Number2134265-2019-05533
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 06/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/18/2022
Device Model Number26605
Device Catalogue Number26605
Device Lot Number0022534095
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/14/2019
Date Manufacturer Received05/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
TRAXCESS14
Patient Outcome(s) Other;
Patient Age80 YR
Patient Weight61
-
-