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

Model Number 45007

Device Problems Leak/Splash (1354); Suction Problem (2170)

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

Event Date 01/14/2022

Event Type  malfunction  

Event Description

It was reported that the device stopped aspirating.A 2.4mm jetstream xc catheter was selected for use in an atherectomy procedure in the superficial femoral artery to treat peripheral artery disease.Early in the procedure, it was observed that the waste bag was not filling, and there was no aspiration.The tubing seemed to be leaking.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device eval 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.Functional analysis was done by completing the setup procedure per the instructions for use.Functional testing was completed, and no leaks were noticed from the baton or any other component on the device.Aspiration testing of the device was performed per the test procedure.The device is tested by using a beaker of water.The device's 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 1 minute 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.Inspection of the remainder of the device revealed no damage or irregularities.

Event Description

It was reported that the device stopped aspirating.A 2.4mm jetstream xc catheter was selected for use in an atherectomy procedure in the superficial femoral artery to treat peripheral artery disease.Early in the procedure, it was observed that the waste bag was not filling, and there was no aspiration.The tubing seemed to be leaking.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: JETSTREAM XC
• Type of Device: CATHETER, 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 Key: 13497397
• MDR Text Key: 285331991
• Report Number: 2134265-2022-01128
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889922
• UDI-Public: 08714729889922
• 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: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/27/2022
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0026695754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1