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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 Shaft; Break; Difficult to Remove ; Catheter
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 NameCHARIOT
Type of DeviceCHARIOT¿ 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
Report Number2134265-2015-06615
Device Sequence Number1
Product CodeDYB
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 09/04/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/30/2015
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/04/2015
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 TREATMENT DATA
Date Received: 09/30/2015 Patient Sequence Number: 1
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