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

Model Number 45007

Device Problem Unexpected Shutdown (4019)

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

Event Date 12/13/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: returned product consisted of a jetstream xc-2.4 atherectomy catheter.The device was visually examined for any shaft damage and the functional testing of the device was completed.The device showed no damage.There was blood in the device.Functional analysis was done by completing the setup procedure per the instructions for use (ifu).The device rotated as designed.Aspiration testing of the device was completed per the test procedure.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 after the 1minute run time is subtracted from the starting milliliters and the final number is the total that was aspirated.Test results showed that this device did not perform as designed per the test procedure specification sheet, withdrawing 26ml of fluid in the 1minute time frame.Inspection of the remainder of the device revealed no damage or irregularities.

Event Description

Reportable based on analysis completed on 25jan2024.It was reported that the device unexpectedly shutdown.A 2.4mm jetstream xc atherectomy catheter was selected for an atherectomy procedure in the superficial femoral artery.After the jetstream was primed, however, air bubbles continued to be seen in the tube during advancement to the lesion.The product was removed off the wire and reprimed.Once in the patient again, the jetstream unexpectedly shutdown and lost activity.The device was exchanged with a new jetstream catheter to complete the procedure, and no patient complications were reported.However, device analysis revealed only failure to evacuate.

• 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: 18707356
• MDR Text Key: 335829560
• Report Number: 2124215-2024-03916
• Device Sequence Number: 1
• Product Code: MCW
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• 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: 0032671477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1