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 - MAPLE GROVE CHARIOT; CHARIOT¿ GUIDING SHEATH
  • 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 - MAPLE GROVE CHARIOT; CHARIOT¿ GUIDING SHEATH Back to Search Results
Model Number H74939277665110
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/12/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the sheath broke.Vascular access was obtained via the right groin.The target lesion was located in the superficial femoral artery (sfa).A chariot guiding sheath was placed.Angioplasty and stent placement were performed.At the end of the procedure, as the physician was coming out, the chariot sheath broke in half leaving half still inside the patient as they were pulling it out.They went ahead and kept pulling the inner wiring of the sheath.When the rest of the device became visible, they grabbed a hemostat to pull the remaining portion of the sheath out of the patient.No patient complications were reported and the patient's status is fine.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a chariot guide sheath.There was blood on the outside and inside the device.Microscopic examination revealed a kink about.5mm from the hub and a kink 15.5cm from the tip.The shaft was detached 18cm from the tip with but still attached by the coil.The coil was stretched proximally 32cm between the shaft separations.The shaft was also damaged on the separated end of the distal half of the separation.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
 
Event Description
It was reported that the sheath broke.Vascular access was obtained via the right groin.The target lesion was located in the superficial femoral artery (sfa).A chariot guiding sheath was placed.Angioplasty and stent placement were performed.At the end of the procedure, as the physician was coming out, the chariot sheath broke in half leaving half still inside the patient as they were pulling it out.They went ahead and kept pulling the inner wiring of the sheath.When the rest of the device became visible, they grabbed a hemostat to pull the remaining portion of the sheath out of the patient.No patient complications were reported and the patient's status is fine.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CHARIOT
Type of Device
CHARIOT¿ GUIDING SHEATH
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key5213368
MDR Text Key30853102
Report Number2134265-2015-07431
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150186
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Remedial Action Recall
Type of Report Initial,Followup
Report Date 10/12/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2018
Device Model NumberH74939277665110
Device Catalogue Number39277-66511
Device Lot Number18351103
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/19/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/30/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/10/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number91107242-FA
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-