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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM SC CATHETER, PERIPHERAL, ATHERECTOMY

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BOSTON SCIENTIFIC CORPORATION JETSTREAM SC CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 45006
Device Problems Material Perforation (2205); Infusion or Flow Problem (2964)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/14/2019
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was reported that a hole in the shaft occurred. A 1. 6mm jetstream sc catheter was selected for use in an atherectomy procedure in the anterior tibial and posterior tibial artery. Upon removing the device from the patient, a hole was noted in the proximal third of the catheter on the underside closer to the pod. No error message displayed. The hole was hindering infusion and proper use. The catheter only primed properly if the hole was covered, preventing a leak. A different catheter was used to complete the procedure. No patient complications were reported. The patient was discharged.
 
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Brand NameJETSTREAM SC
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORK LIMITED
cork business technology park
model farm road
cork
EI
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key8478080
MDR Text Key140769485
Report Number2134265-2019-03327
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130637
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 04/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/20/2020
Device Model Number45006
Device Catalogue Number45006
Device Lot Number0022679462
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 Received03/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/20/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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