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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE CHARIOT; CHARIOT¿ GUIDING SHEATH

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BOSTON SCIENTIFIC - MAPLE GROVE CHARIOT; CHARIOT¿ GUIDING SHEATH Back to Search Results
Model Number H74939277745110
Device Problems Break (1069); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/04/2015
Event Type  Injury  
Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
 
Event Description
It was reported that removal difficulties occurred.Vascular access was obtained via the left side.The chronic totally occluded (cto) lesion was located in the highly calcified right superficial femoral artery (sfa).The iliac was also noted to be highly calcified.A chariot guiding sheath was selected.The physician was unable to get through the cto after about 45 minutes.While removing the sheath, the sheath broke near the top and remained inside the patient.The physician accessed the right side, placed a sheath, pushed the sheath up a bit.The surgeon then made a small incision and was able to fish out the remaining portion of the chariot guiding sheath.No patient complications were reported and the patient's status is fine.
 
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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 Key5113931
MDR Text Key27125360
Report Number2134265-2015-06615
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
Type of Report Initial
Report Date 09/04/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2015
Device Model NumberH74939277745110
Device Catalogue Number39277-74511
Device Lot Number18079822
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/04/2015
Initial Date FDA Received09/30/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/21/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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