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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK JETSTREAM® XC ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY

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BOSTON SCIENTIFIC - CORK JETSTREAM® XC ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 112264-001
Device Problem Aspiration Issue (2883)
Patient Problem Thrombosis (2100)
Event Date 12/11/2017
Event Type  Injury  
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 and also functionality of the device. Functional analysis was done by completing the aspiration testing. The device is tested by using a 100ml beaker of water. The devices tip is submerged in a beaker of fluid and the device is run for a period of 1 minute. The final milliliters of fluid that the beaker shows is subtracted from the starting milliliters and the final number is the total that was aspirated (100ml¿ 89ml
=
11ml). Test results showed that the device did not perform as designed per the test procedure specification sheet withdrawing 11ml of fluid in the 1 minute time frame. Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities. Dissection of the catheter shaft showed that the aspiration lumen was occluded with a heavy clot burden which contributed to the aspiration issues. The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).
 
Event Description
It was further reported that no error message occurred. Following the aspiration issue, the device was re-primed and advanced back into the patient to aspirate the clot. Aspiration was still not working well. At this point the physician chose to use a new device for aspirating the clot. There was no physical catheter issue.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that there was a loss of aspiration and thrombus occurred. A 2. 1 mm jetstream® xc atherectomy catheter was selected for use in an atherectomy procedure in the superficial femoral artery. Midway through the procedure, aspiration stopped working. The vessel clotted. Another jetstream, some medications and some angioplasty were used to resolve the issue. The patient was doing okay after the procedure.
 
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Brand NameJETSTREAM® XC ATHERECTOMY CATHETER
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC - CORK
business and technology park
model farm road
cork
EI
Manufacturer (Section G)
BOSTON SCIENTIFIC - CORK
business and technology park
model farm road
cork
EI
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7159735
MDR Text Key250263397
Report Number2134265-2017-12792
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,Followup
Report Date 12/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/12/2019
Device Model Number112264-001
Device Catalogue NumberPV31300
Device Lot Number21247941
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/05/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/12/2017
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: 01/03/2018 Patient Sequence Number: 1
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