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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 Problem Mechanical Problem (1384)
Patient Problems Embolism (1829); Hemorrhage/Bleeding (1888); Pseudoaneurysm (2605)
Event Date 08/21/2020
Event Type  Injury  
Event Description
It was reported that embolism, hemorrhage and pseudoaneurysm occurred. A contralateral approach was used to access the 70-80% stenosed target lesion located in the moderately calcified left superficial femoral artery (sfa) and popliteal artery. A non-bsc wire and catheter was used to cross the lesion successfully. The wire was exchanged to a 0. 014 inch thruway wire. The wire was exchanged again for a non-bsc embolic protection system. Then a 2. 1mm jetstream xc atherectomy catheter was prepared for use. The device primed properly and was inserted into the patient. Atherectomy was initiated and the jetstream was passed slowly through the lesion and pulled back via rex mode. A second passage was made with blades down. During the third pass with blades up, the device became momentarily caught in the lesion though did cause any problems. The device was pulled back a bit and then atherectomy was further performed in blades up mode. The device was pulled back out of the lesion using rex mode. Post-dilation was performed successfully with two ranger balloons, 4mm and 5mm diameter. There was little blood flow when the lesion was checked and it was suspected that the non-bsc embolic protection system may have been the cause so it was removed. The minimal blood flow persisted and embolism was observed. A non-bsc catheter and non-bsc separator were used to perform a thrombectomy. It was noted that the mid-sfa was bumpy at the location where the jetstream had become momentarily caught. Hemorrhage and pseudoaneurysm in the mid-sfa were observed and a non-bsc stent graft was placed to remedy this. The physician's opinion was that the jetstream or the non-bsc thrombectomy device caused the hemorrhage and pseudoaneurysm. The lower leg tibial vessels were dilated to treat stenosis. No further patient complications were reported and patient was reported as stable post procedure.
 
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Brand NameJETSTREAM XC ATHERECTOMY CATHETER
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 Key10505737
MDR Text Key206098168
Report Number2134265-2020-12190
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K130637
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0025686868
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/08/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/08/2020 Patient Sequence Number: 1
Treatment
MEDTRONIC SPIDER EMBOLIC PROTECTION SYSTEM; PENUMBRA CAT6 CATHETER; PENUMBRA SEPARATOR; RANGER BALLOON 4MM; RANGER BALLOON 5MM; THRUWAY .014 GUIDEWIRE
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