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

Model Number 45007

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: date of event was unknown, used the first day in the month it was reported.

Event Description

It was reported that a loss of aspiration occurred.A 2.4mm jetstream xc catheter was selected for a procedure.During the procedure, the catheter lost aspiration.The procedure was completed with another of the same device.There were no patient complications reported.

Manufacturer Narrative

B3: date of event was unknown, used the first day in the month it was reported.Device analysis by mfr: 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.The device is tested by using a 100ml beaker of water.Test results showed that this device did not perform as designed per the test procedure specification sheet withdrawing 3ml of fluid in the 1 minute time frame.Inspection of the remainder of the device revealed no damage or irregularities.

Event Description

It was reported that a loss of aspiration occurred.A 2.4mm jetstream xc catheter was selected for a procedure.During the procedure, the catheter lost aspiration.The procedure was completed with another of the same device.There were no patient complications reported.

• Brand Name: JETSTREAM XC
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10656248
• MDR Text Key: 210640211
• Report Number: 2134265-2020-13920
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889922
• UDI-Public: 08714729889922
• Combination Product (y/n): N
• PMA/PMN Number: K133023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0025787832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Date Manufacturer Received: 10/15/2020
• Patient Sequence Number: 1