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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM PV ATHERECTOMY SYSTEM CONSOLE; CATHETER, PERIPHERAL, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION JETSTREAM PV ATHERECTOMY SYSTEM CONSOLE; CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 45010
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/04/2023
Event Type  malfunction  
Event Description
It was reported that the console had an unresolved pod error, and the procedure was cancelled.A jetstream pv atherectomy system console was selected for an atherectomy procedure.During preparation, however, there was a pod error.Two other jetstream catheters from different batches were tried, but the error message was not resolved.The procedure was then cancelled.There were no patient complications reported.
 
Manufacturer Narrative
Device evaluation by manufacturer: jetstream console s/n (b)(6) was tested per cis jetstream functional test procedure.Jetstream s/n jet0187 showed the cracked cosmetic catheter hang, and damaged durable label.Console was attached to the jetstream gold test set up and the cis jetstream functional test was performed.Troubleshooting confirmed pod error.Pcba display replaced with the gold unit display board and retested; this time, there was no observation of pod error at any time during functional test with gold unit display board.Therefore, the allegation console showed error message (pod) was confirmed during investigation.
 
Event Description
It was reported that the console had an unresolved pod error, and the procedure was cancelled.A jetstream pv atherectomy system console was selected for an atherectomy procedure.During preparation, however, there was a pod error.Two other jetstream catheters from different batches were tried, but the error message was not resolved.The procedure was then cancelled.There were no patient complications reported.
 
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Brand Name
JETSTREAM PV ATHERECTOMY SYSTEM CONSOLE
Type of Device
CATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
150 baytech dr.
san jose CA 95134
Manufacturer Contact
rachel shields shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key17962470
MDR Text Key326035346
Report Number2124215-2023-56892
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/16/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number45010
Device Catalogue Number45010
Device Lot NumberJET0187
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/25/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/31/2016
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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