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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM SC ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION JETSTREAM SC ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 45006
Device Problem Entrapment of Device (1212)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/16/2022
Event Type  malfunction  
Event Description
It was reported that the catheter became entrapped on the guidewire.A jetstream sc 1.6mm atherectomy catheter was selected for an anterior tibial atherectomy procedure to treat peripheral arterial disease.The catheter was used together with a 0.014 thruway guidewire.When backloading the jetstream catheter onto the thruway 0.014 wire, however, it would not advance any further.The catheter became stuck on the guidewire.The wire was removed, and a new thruway wire was tried, but the catheter became entrapped again.The wire and the catheter were removed, and the atherectomy procedure was discontinued.It was noted that it was difficult to remove the guidewire from the catheter once outside the patient.Balloon angioplasty was performed to complete the procedure.There were no patient complications reported.
 
Event Description
It was reported that the catheter became entrapped on the guidewire.A jetstream sc 1.6mm atherectomy catheter was selected for an anterior tibial atherectomy procedure to treat peripheral arterial disease.The catheter was used together with a 0.014 thruway guidewire.When backloading the jetstream catheter onto the thruway 0.014 wire, however, it would not advance any further.The catheter became stuck on the guidewire.The wire was removed, and a new thruway wire was tried, but the catheter became entrapped again.The wire and the catheter were removed, and the atherectomy procedure was discontinued.It was noted that it was difficult to remove the guidewire from the catheter once outside the patient.Balloon angioplasty was performed to complete the procedure.There were no patient complications reported.
 
Manufacturer Narrative
Device evaluation by manufacturer: the device returned to boston scientific consisted of a jetstream atherectomy catheter.The device was visually and microscopically examined for any damage.Visual examination revealed a kink to the sheath 2cm from the strain relief.Microscopic examination revealed no additional damages.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Product analysis found damage that could have contributed to the reported event.
 
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Brand Name
JETSTREAM SC 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
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key16016577
MDR Text Key306265647
Report Number2124215-2022-53780
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeEI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/01/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/01/2024
Device Model Number45006
Device Catalogue Number45006
Device Lot Number0028979489
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/16/2022
Initial Date FDA Received12/20/2022
Supplement Dates Manufacturer Received01/31/2023
Supplement Dates FDA Received02/01/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/03/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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