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

Model Number 45007

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 08/02/2023

Event Type  malfunction  

Event Description

It was reported that the device rotation could not be deactivated.A 2.1mm jetstream xc catheter was selected for use in the superficial femoral artery (sfa).The device was successfully used to cut through the lesion in blades down mode.When the physician then attempted to turn the device blade rotation off, the blades continued to rotate.The entire system was then disconnected from the power supply to turn off the device.The procedure was completed using an alternative method.There were no patient complications.

Event Description

It was reported that the device rotation could not be deactivated.A 2.1mm jetstream xc catheter was selected for use in the superficial femoral artery (sfa).The device was successfully used to cut through the lesion in blades down mode.When the physician then attempted to turn the device blade rotation off, the blades continued to rotate.The entire system was then disconnected from the power supply to turn off the device.The procedure was completed using an alternative method.There were no patient complications.

Manufacturer Narrative

Device evaluation by manufacturer: the returned product to boston scientific consisted of a jetstream xc-2.1 atherectomy catheter.The device was visually and microscopically examined for any shaft damage.Visual examination showed a bend on the catheter shaft located 77.5cm from the tip and a severe kink located at the strain relief of the device.The device was set up and functionally tested per the instructions for use (ifu).The device primed; however, no tip rotation was seen.The severe kink at the strain relief most likely severed the drive shaft or damaged it enough to where the tip would not rotate.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The complaint of the device having electrical issues and not stopping after releasing the button was not confirmed; however, shaft damage was confirmed.

• Brand Name: JETSTREAM XC ATHERECTOMY CATHETER
• 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: 17551987
• MDR Text Key: 321233035
• Report Number: 2124215-2023-43316
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• 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: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• 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: 0031486087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1