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 10/22/2019

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: the patient was about (b)(6) years old.Device evaluated by manufacturer: the returned product consisted of a jetstream xc 2.4mm atherectomy catheter.Visual examination of the device showed no damage or irregularities.Functional analysis was done by completing the setup procedure and performing aspiration testing of the device.Test results showed that this device did perform per specification aspirating 43ml 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 there was a loss of aspiration.A 2.4mm jetstream xc catheter was selected for use for an atherectomy procedure in the left leg thigh.The jetstream catheter was primed and platformed outside the patient during preparation.During the procedure, the device ran for 3 seconds and then lost aspiration.The device was pulled out from the patient's body, and re-primed, placed back in, but it had the same issue.The device was removed and the procedure was successfully completed with a new 2.4mm jetstream xc catheter.There were no patient complications reported.The patient's status post procedure was okay.

• 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 CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9295367
• MDR Text Key: 170120783
• Report Number: 2134265-2019-13552
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 0024158391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2019
• Initial Date FDA Received: 11/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1