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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 Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/01/2021
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr: the device returned to boston scientific consisted of a jetstream atherectomy catheter. The device was visually and microscopically examined for any damage. Visual examination and microscopic examination revealed no damages. A test guidewire was attempted to be inserted into the tip but was unable to pass through. The tip was soaked in a water bath for several days but the obstruction was still present. The tip was cut off and a piece of foreign material was found inside. Ftir testing of the foreign material suggests that it is wool. Inspection of the remainder of the device, revealed no other damage or irregularities.
 
Event Description
Reportable based on device analysis completed on 06aug2021. It was reported that there was difficulty advancing the device over the wire. A 2. 1mm jetstream xc catheter was selected for a patient procedure for a right superficial femoral artery occlusion. The catheter was used, and then removed so the physician could treat the lesion with another method. When they went to reinsert the jetstream catheter, it would not advance over the wire at the tip end. Another of the same device was used to complete the procedure with the same wire. However, device analysis revealed foreign material in the tip of the device.
 
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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 Key12377416
MDR Text Key268466839
Report Number2134265-2021-10786
Device Sequence Number1
Product Code MCW
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 08/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0027087791
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/06/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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