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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 Problems Entrapment of Device (1212); Mechanical Problem (1384); Difficult or Delayed Activation (2577); Noise, Audible (3273)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/26/2022
Event Type  malfunction  
Event Description
It was reported that the catheter was entrapped on the guidewire.A jetstream xc atherectomy catheter was selected for use.The target lesion was located in the superficial femoral artery (sfa).During use, it was noted that the catheter wouldn't activate continuously.The device lost all functions.The noise from the device was different than expected.After ten minutes of trying to activate the device, it became entrapped on the non-bsc guidewire.The procedure was completed with a new jetstream catheter.There were no patient complications.
 
Manufacturer Narrative
Device eval by mfr: the device was returned and analysis was completed.The returned device consisted of a jetstream atherectomy catheter.The device was visually and microscopically examined for any damage.Visual examination revealed multiple buckling to the sheath.Microscopic examination revealed no additional damages.Device to device interaction test was performed and a test guidewire was able to pass through without any issues.The device was functionally tested and it was able to prime and run as intended.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 catheter was entrapped on the guidewire.A jetstream xc atherectomy catheter was selected for use.The target lesion was located in the superficial femoral artery (sfa).During use, it was noted that the catheter wouldn't activate continuously.The device lost all functions.The noise from the device was different than expected.After ten minutes of trying to activate the device, it became entrapped on the non-bsc guidewire.The procedure was completed with a new jetstream catheter.There were no patient complications the device was returned and analysis was completed on 25aug2022.The returned device consisted of a jetstream atherectomy catheter.The device was visually and microscopically examined for any damage.Visual examination revealed multiple buckling to the sheath.Microscopic examination revealed no additional damages.Device to device interaction test was performed and a test guidewire was able to pass through without any issues.The device was functionally tested and it was able to prime and run as intended.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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
model farm road
cork
EI  
Manufacturer Contact
jay johnson johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15247976
MDR Text Key298136580
Report Number2124215-2022-29931
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeIS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0029619778
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/20/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ABBOTT GUIDEWIRE; ABBOTT GUIDEWIRE
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