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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM XC; CATHETER, PERIPHERAL, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION JETSTREAM XC; CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 45007
Device Problems Break (1069); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/25/2019
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 60's.
 
Event Description
It was reported that the outer sheath of the catheter pulled off during the procedure.A 2.4mm jetstream xc catheter was selected for an atherectomy procedure in the left lower extremity.During introduction, resistance occurred with the catheter upon entering the 7fr sheath.The catheter was pulled back and it was noted that the outer sheath of the catheter was pulled off at the distal end.The device never made it through the sheath.A charger balloon was utilized to treat the diseased superficial femoral artery (sfa).There were no patient complications.The patient had adequate percutaneous transluminal angioplasty (pta) results.
 
Manufacturer Narrative
Age at time of event: 60's.Device eval by manufacturer:returned product consisted of a jetstream xc-2.4 atherectomy catheter.The device was visually and microscopically examined for any shaft damage.It was notice that there was multiple small buckling/kink located from the tip, proximal to 13cm.The damage that was noticed is consistent with procedural issues by pushing, pulling and torqueing of the device in an introducer sheath, tortuous anatomy or a heavily calcified lesion.The device was set-up and functionally tested and the device functioned as designed.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 outer sheath of the catheter pulled off during the procedure.A 2.4mm jetstream xc catheter was selected for an atherectomy procedure in the left lower extremity.During introduction, resistance occurred with the catheter upon entering the 7fr sheath.The catheter was pulled back and it was noted that the outer sheath of the catheter was pulled off at the distal end.The device never made it through the sheath.A charger balloon was utilized to treat the diseased superficial femoral artery (sfa).There were no patient complications.The patient had adequate percutaneous transluminal angioplasty (pta) results.
 
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Brand Name
JETSTREAM XC
Type of Device
CATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8776411
MDR Text Key150574819
Report Number2134265-2019-07959
Device Sequence Number1
Product Code MCW
UDI-Device Identifier08714729889922
UDI-Public08714729889922
Combination Product (y/n)N
PMA/PMN Number
K133023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/11/2021
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0023628451
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/05/2019
Date Manufacturer Received07/19/2019
Patient Sequence Number1
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