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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 Problems Break (1069); Physical Resistance/Sticking (4012)
Patient Problems Vasoconstriction (2126); Cramp(s) /Muscle Spasm(s) (4521)
Event Date 01/19/2022
Event Type  Injury  
Manufacturer Narrative
Initial reporter phone: (b)(6).
 
Event Description
It was reported that removal difficulty occurred.A direxion was selected for microcatheterization of an endoleak of the abdominal aorta via the arc of riolan.After embolization, major resistance occurred withdrawing the device causing peeling of the external frame of the microcatheter.An integrated portion of the microcatheter was found to aide in removal without leaving a fragment in the sma or the arc of riolan.A spasm was noticed at the beginning of the arc of riolan, with no prior functional repercussions.
 
Manufacturer Narrative
Initial reporter phone: (b)(6).
 
Event Description
It was reported that removal difficulty occurred.A direxion was selected for microcatheterization of an endoleak of the abdominal aorta via the arc of riolan.After embolization, major resistance occurred withdrawing the device causing peeling of the external frame of the microcatheter.An integrated portion of the microcatheter was found to aide in removal without leaving a fragment in the sma or the arc of riolan.A spasm was noticed at the beginning of the arc of riolan, with no prior functional repercussions.
 
Manufacturer Narrative
Initial reporter phone: (b)(4).H6 patient codes, evaluation conclusion codes - updated.Device evaluated by mfr: the direxion was returned to boston scientific for analysis.The device was inspected for any damage or irregularities.A fracture 40.9 cm from the hub was noted, but not a break.Kinks were measured at 51.8 cm and 52.9 cm from the hub.The report of peeling of the nitinol shaft was not confirmed.The device could not be inserted into a guide catheter due to the fracture so the report of friction could not be determined.
 
Event Description
It was reported that removal difficulty occurred.A direxion was selected for microcatheterization of an endoleak of the abdominal aorta via the arc of riolan.After embolization, major resistance occurred withdrawing the device causing peeling of the external frame of the microcatheter.An integrated portion of the microcatheter was found to aide in removal without leaving a fragment in the sma or the arc of riolan.A spasm was noticed at the beginning of the arc of riolan, with no prior functional repercussions.
 
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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
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key13580853
MDR Text Key285986567
Report Number2134265-2022-01125
Device Sequence Number1
Product Code KRA
UDI-Device Identifier08714729839415
UDI-Public08714729839415
Combination Product (y/n)N
Reporter Country CodeFR
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,Followup
Report Date 07/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/05/2023
Device Model Number80618
Device Catalogue Number80618
Device Lot Number0027608193
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/27/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/05/2021
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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