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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM XC ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION JETSTREAM XC ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 45007
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/01/2019
Event Type  malfunction  
Event Description
It was reported than a foreign object was found inside the packaging.A 2.4mm jetstream xc catheter was selected for an atherectomy procedure in the femoral artery.During preparation for the procedure, the packaging was opened.A foreign object was found in the product near the catheter tip section.The foreign object was removed by the physician.The procedure was completed with the original device.The patient is fine and experienced no adverse effects.
 
Event Description
It was reported than a foreign object was found inside the packaging.A 2.4mm jetstream xc catheter was selected for an atherectomy procedure in the femoral artery.During preparation for the procedure, the packaging was opened.A foreign object was found in the product near the catheter tip section.The foreign object was removed by the physician.The procedure was completed with the original device.The patient is fine and experienced no adverse effects.
 
Manufacturer Narrative
Device analysis by mfr: the returned product consisted of a jetstream xc 2.4 mm atherectomy catheter.Visual examination of the device showed damage in the form of kinks located 2cm and 116cm from the tip.The devices tip and surrounding area was microscopically inspected for any foreign objects.The complaint for a foreign object was not confirmed.The functionality of the device was checked by setting up the product per directions for use.The device primed and functioned as designed.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.
 
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Brand Name
JETSTREAM XC ATHERECTOMY CATHETER
Type of Device
CATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8713842
MDR Text Key148533659
Report Number2134265-2019-07135
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
PMA/PMN Number
K130637
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
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 Received06/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/09/2019
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0021357027
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2019
Date Manufacturer Received07/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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