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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 Problems Entrapment of Device (1212); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/09/2021
Event Type  malfunction  
Event Description
It was reported that the device became entrapped on the wire. A 2. 1mm jetstream xc catheter was selected for a left lower extremity runoff procedure for peripheral artery disease in the superficial femoral artery (sfa). The lesion had mild calcification, mild tortuosity, and was a chronic total occlusion. During the procedure the device had some issues tracking/crossing the sfa lesion. Once several passes were made physician attempted to remove the device, but it would not come off of the non-bsc wire. They attempted to rex and advance the device to loosen it from the wire without success. Finally had to remove everything as one unit out of the patient and then recross lesion. No visible damage was noted on the device. Procedure completed successfully with another of the same device. No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: the returned product consisted of a jetstream xc 2. 1. A non-compatible filter wire was stuck in the device. The device and the catheter shaft were analyzed for damage. The guidewire was in the device when received and analyzed. The catheter shaft showed multiple areas of buckling located 1cm, 88. 5cm and 89. 5cm from the tip. A severe kink was noticed approximately 55cm from the tip. The guidewire showed scraped coating at the tip. The guidewire tip was protruding from the distal end of the device 9. 5cm and from the proximal end of the device 154. 5cm. The device was set up per the instructions for use. The device primed and functioned intermittently due to the shaft damage. During the functional test, the gear slid off the shaft within 20 seconds of functionally testing. The blades stopped spinning. The pod was opened and confirmed the failure of the gear sliding off the shaft. Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities. The jetstream device instructions for use lists the compatible guidewires that are to be used with the jetstream device. The guidewire that was used during this procedure was not on the compatible list. The wire used was a spider. 014 filter guidewire. Use of any non-compatible guidewire may compromise performance or damage to the jetstream system. Compatible guidewires: jetwire 0. 014 in 0. 36 mm 300 cm. Thruway 0. 014 in 0. 36 mm 300 cm. Abbott vascular hi-torque spartacore. Abbott vascular hi-torque iron man.
 
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Brand NameJETSTREAM XC
Type of DeviceCATHETER, 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
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12905588
MDR Text Key281517023
Report Number2134265-2021-14620
Device Sequence Number1
Product Code MCW
UDI-Device Identifier08714729889892
UDI-Public08714729889892
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0028057459
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/21/2021
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/30/2021 Patient Sequence Number: 1
Treatment
GUIDEWIRE: SPIDER RX 5.0 - MEDTRONIC
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