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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 Suction Problem (2170)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/02/2023
Event Type  malfunction  
Event Description
It was reported that the device was not aspirating.A jetstream xc was selected for use in the endovascular therapy procedure to treat a case of peripheral artery disease.The target lesion was located in the superficial femoral artery and was reported to be 90% stenosed with moderate tortuosity and severe calcification.At the start of the procedure, it was observed that the jetstream failed to aspirate.The jetstream was exchanged for another to complete the procedure.There were no reported patient injuries.
 
Manufacturer Narrative
Device analysis: returned product consisted of a jetstream xc-2.4 atherectomy catheter.The device was visually examined for any shaft damage and functional testing of the device was completed.The device primed and ran.Test results showed that the device performed as designed.Inspection of the remainder of the device revealed no damage or irregularities.The complaint was not confirmed for aspiration issues.
 
Event Description
It was reported that the device was not aspirating.A jetstream xc was selected for use in the endovascular therapy procedure to treat a case of peripheral artery disease.The target lesion was located in the superficial femoral artery and was reported to be 90% stenosed with moderate tortuosity and severe calcification.At the start of the procedure, it was observed that the jetstream failed to aspirate.The jetstream was exchanged for another to complete the procedure.There were no reported patient injuries.
 
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Brand Name
JETSTREAM XC
Type of Device
CATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
model farm road
cork T12 Y K88
EI   T12 YK88
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18210320
MDR Text Key329027344
Report Number2124215-2023-65856
Device Sequence Number1
Product Code MCW
UDI-Device Identifier08714729889922
UDI-Public08714729889922
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K133023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0032173369
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/30/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/08/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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