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

Model Number H74939277645110

Device Problem Occlusion Within Device (1423)

Patient Problem Thrombus (2101)

Event Date 10/29/2015

Event Type  Injury  

Manufacturer Narrative

Age at time of event : 60s.(b)(4).It is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that the sheath occluded with clot.Vascular access was obtained via the femoral artery.As the physician got the 6f, 45 cm, st, cc chariot guiding sheath in place, the physician tried pulling back blood to flush with saline; however, the physician could not pull back blood.The physician believed the patient clotted off.The sheath was removed.The physician realized that he could not even flush the sheath at all.The hub of the sheath was clotted right off.A big clot was found inside the hub.The hub of the chariot sheath was exchanged to a hub from a non-bsc sheath and used in the completion of the procedure.No patient complications were reported and the patient's status if fine.

• 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 Key: 5247839
• MDR Text Key: 32088320
• Report Number: 2134265-2015-07957
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: H74939277645110
• Device Catalogue Number: 39277-64511
• Device Lot Number: 18231361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention