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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DIREXION; CATHETER, CONTINUOUS FLUSH
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BOSTON SCIENTIFIC CORPORATION DIREXION; CATHETER, CONTINUOUS FLUSH Back to Search Results
Model Number 80618
Device Problem Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/09/2021
Event Type  malfunction  
Event Description
It was reported that the outer shaft ruptured.A direxion microcatheter was selected for use in an embolization procedure.During the procedure, a loop formed, and the outer shaft ruptured in the middle of the catheter, outside the patient.The device was removed from the patient intact.The procedure was completed with another of the same device.No patient complications were reported.
 
Manufacturer Narrative
Device eval by manufacturer: the direxion microcatheter was returned to boston scientific for analysis.The device shaft was analyzed for any damage.The shaft was fractured in two locations: 17.7cm and 62cm from the hub.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Fractures were confirmed.
 
Event Description
It was reported that the outer shaft ruptured.A direxion microcatheter was selected for use in an embolization procedure.During the procedure, a loop formed, and the outer shaft ruptured in the middle of the catheter, outside the patient.The device was removed from the patient intact.The procedure was completed with another of the same device.No patient complications were reported.
 
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Brand Name
DIREXION
Type of Device
CATHETER, CONTINUOUS FLUSH
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
model farm road
cork
EI  
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12215048
MDR Text Key263098495
Report Number2134265-2021-09394
Device Sequence Number1
Product Code KRA
UDI-Device Identifier08714729839354
UDI-Public08714729839354
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K142259
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/19/2023
Device Model Number80618
Device Catalogue Number80618
Device Lot Number0027340086
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/19/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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