MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM XC; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number 45007

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2024

Event Type  malfunction  

Event Description

It was reported the device was leaking a mixture of fluids.A 2.1mm jetstream xc catheter was selected for interventional procedure in an occluded superficial femoral artery (sfa).The physician noted the device was leaking a mixture of floods from the bottom of the control unit, suspected to be blood.There were no patient complications.

Event Description

It was reported the device was leaking a mixture of fluids.A 2.1mm jetstream xc catheter was selected for interventional procedure in an occluded superficial femoral artery (sfa).The physician noted the device was leaking a mixture of fluids from the bottom of the control unit, suspected to be blood.There were no patient complications.

Manufacturer Narrative

Device evaluation by manufacturer: the device returned to boston scientific consisted of a jetstream xc-2.1 atherectomy catheter.The device was visually examined for any shaft damage.Visual examination showed no damage on the catheter shaft.The device was inserted into the console and set up per the instruction for use.No issues were noticed during functionality of the device.There was a small leak at the pod; however, this is a normal function of the device and does not affect the functionality.Inspection of the remainder of the device revealed no damage or irregularities.The complaint of the device leaking fluid due to an issue with the device was not confirmed.

• 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 Key: 18634193
• MDR Text Key: 334760872
• Report Number: 2124215-2024-05017
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889892
• UDI-Public: 08714729889892
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0032568792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1