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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 Problem Entrapment of Device (1212)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/30/2020
Event Type  malfunction  
Event Description
It was reported that the catheter became stuck on the wire.A 2.4 mm jetstream xc atherectomy catheter was selected for a procedure in the left superficial femoral artery (sfa).During the procedure, the jetstream catheter was advanced over a thruway guidewire and the jetstream ran for 7:23 minutes.Then, catheter became stuck on the guidewire and it could not be removed.The catheter and the wire were removed together from the patient.There were no patient complications reported.
 
Event Description
It was reported that the catheter became stuck on the wire.A 2.4 mm jetstream xc atherectomy catheter was selected for a procedure in the left superficial femoral artery (sfa).During the procedure, the jetstream catheter was advanced over a thruway guidewire and the jetstream ran for 7:23 minutes.Then, catheter became stuck on the guidewire and it could not be removed.The catheter and the wire were removed together from the patient.There were no patient complications reported.
 
Manufacturer Narrative
Corrections to field h6: method, results, and conclusion.Device analysis by mfr: the returned product consisted of a jetstream xc 2.4.The guidewire was in the device when returned.The device and the catheter shaft were analyzed for damage.The baton and the electrical connections were cut off from the customer site.The catheter shaft showed 1 kink and multiple areas of buckling of the shaft.The kink was located 63.5cm from the tip.The guidewire that was in the device was not sticking out of the distal end.The guidewire was sticking out of the proximal end approximately 220cm.The wire was pulled from the device with difficulty and showed tip damage when removed.It looked like the jetstream device was run of the coils of the tip.The device could not be functionally tested due to the baton and electrical connections being cut from the device.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.
 
Manufacturer Narrative
Device analysis by mfr: the returned product consisted of a jetstream xc 2.4.The guidewire was in the device when returned.The device and the catheter shaft were analyzed for damage.The baton and the electrical connections were cut off from the customer site.The catheter shaft showed 1 kink and multiple areas of buckling of the shaft.The kink was located 63.5cm from the tip.The guidewire that was in the device was not sticking out of the distal end.The guidewire was sticking out of the proximal end approximately 220cm.The wire was pulled from the device with difficulty and showed tip damage when removed.It looked like the jetstream device was run of the coils of the tip.The device could not be functionally tested due to the baton and electrical connections being cut from the device.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 became stuck on the wire.A 2.4 mm jetstream xc atherectomy catheter was selected for a procedure in the left superficial femoral artery (sfa).During the procedure, the jetstream catheter was advanced over a thruway guidewire and the jetstream ran for 7:23 minutes.Then, catheter became stuck on the guidewire and it could not be removed.The catheter and the wire were removed together from the patient.There were no patient complications reported.
 
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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 Key10705327
MDR Text Key212114676
Report Number2134265-2020-14403
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,Followup
Report Date 12/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/16/2022
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0025601183
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2020
Date Manufacturer Received12/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
THRUWAY GUIDEWIRE; THRUWAY GUIDEWIRE; THRUWAY GUIDEWIRE; THRUWAY GUIDEWIRE
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