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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 Material Rupture (1546); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/15/2019
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a jetstream xc 2. 1 atherectomy catheter. The device was visually examined for any shaft damage. Visual examination notice that there were multiple areas of buckling/kinks. The locations of the damage were from the tip proximal to 46cm. Visual examination noticed that the infusion line had burst proximal the buckling/kinks. The location of the burst infusion line was approximately 49cm to 54cm from the tip. The damage that was notice is consistent with sheath interference during the procedure. Pushing, pulling and torqueing of the device could possibly cause the damage that was noticed. The buckling/kinks on the shaft causes the fluid to back up inside of the infusion sheath and causes the infusion sheath to burst proximal of the damage. The device was set-up and functionally tested per the dfu and the device functioned as designed except for the leaking at the burst infusion line. Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities. Although it was reported that the device was inserted into the body but not ran, the presence of blood in the guidewire lumen and the waste bag is indicative of handling beyond simply entering the body and not running the device.
 
Event Description
It was reported that the catheter ruptured. A 2. 1mm jetstream xc catheter was selected for an atherectomy procedure in the lower extremity. The catheter was prepped normally and pushed into the sheath. The catheter could not be pushed any further; therefore the device was pulled out prior to activation. It was noted that the outside plastic coating bubbled up, peeled away and ruptured. Another of the same device was used to complete the procedure. No patient complications were reported and the patient's status was fine.
 
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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 CORK LIMITED
cork business technology park
model farm road
cork
EI
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key8483502
MDR Text Key140928280
Report Number2134265-2019-03380
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130637
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 04/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/03/2020
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0022746842
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/18/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/04/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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