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

Model Number 45007

Device Problem Suction Problem (2170)

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

Event Date 03/17/2022

Event Type  malfunction  

Event Description

It was reported the device lost aspiration.The target lesion stenosis was estimated at greater than 90%, moderately tortuous and located in the superficial femoral artery (sfa).A 2.4mm jetstream xc catheter was selected for use in an atherectomy procedure.The device was successfully primed.The device made it's first pass through the lesion in blades down mode.However, it was noticed that no blood was being aspirated.Air was observed in the tubing.The device was removed, however, it could not be re-primed as air was still observed in the tubing.A new jetstream catheter was selected.The procedure was successfully completed.There were no patient consequences.

Manufacturer Narrative

Device eval by mfr: the device was returned and analysis was completed.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.Aspiration testing of the device was done per the test procedure using a 100ml beaker of water.Test results showed that this device did not perform as designed per the test procedure specification sheet.Inspection of the remainder of the device revealed no damage or irregularities.

• 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: 14023503
• MDR Text Key: 288686644
• Report Number: 2134265-2022-03359
• 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
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2023
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0028385852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1