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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 Entrapment of Device (1212); Difficult to Remove (1528); Difficult to Advance (2920); Material Deformation (2976); Naturally Worn (2988)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/16/2020
Event Type  malfunction  
Manufacturer Narrative
Device analysis by mfr: visual examination showed that the shaft had buckling/kinks located from the tip proximal to 24cm. There was folding or buckling behind the tip located at 1. 5cm. The device was set-up and functionally tested. The device primed and ran as designed. The device was tested for a period of 2 minutes with no issues. Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
 
Event Description
It was reported that the device was difficult to remove. The target lesion was located in the superficial femoral artery (sfa). A 1. 6mm jetstream sc catheter was selected for use in an atherectomy procedure. The device performed normally in the first 10 cm of the sfa, however halfway down the sfa the device kinked and would not advance. The device itself did not lose functionality. The physician decided to remove and inspect the device. It was difficult to remove the device though it was in rex mode and it appeared to be stuck. After a minute of slow pulling, the device was removed without any harm to the sfa. The infusion line was worn from 1cm to 10cm from behind the cutting head. A new device, different model, was selected to complete the procedure. The patient experienced no adverse effects.
 
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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 CORPORATION
model farm road
cork
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10385237
MDR Text Key202210452
Report Number2134265-2020-10767
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/01/2022
Device Model Number45006
Device Catalogue Number45006
Device Lot Number0025298862
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/03/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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