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

Model Number 45007

Device Problems Mechanical Problem (1384); Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2020

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: (b)(6).Device evaluated by manufacturer: visual examination of the shaft and remainder of the device showed damage in the form of 1 kink located 6.5cm from the tip.There was buckling/kinking located 1.5cm from the tip.The functionality of the device was checked by setting up the product per the directions for use.The device primed as designed.The device was functionally tested, and the device did not rotate as designed.No errors were noticed on the console.Inspection of the remainder of the device, apart from the observed damage revealed no damage or irregularities.

Event Description

It was reported that the device had a loss of rotation.A 2.4mm jetstream xc catheter was selected for atherectomy procedure in the left superficial femoral artery (sfa).During the procedure, the device advanced further down to the sfa.As the device was advancing proximal popliteal area, the device stalled and the device lost rotation.It did not show any error message.The physician decided to run it again but it did not work.The rex would not engage or advance.The device was removed manually from the patient and the procedure was completed successfully by a balloon angioplasty and another stents.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
• 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: 9774205
• MDR Text Key: 181825171
• Report Number: 2134265-2020-02365
• 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: 03/02/2020

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 Expiration Date: 04/07/2021
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0023758299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2020
• Initial Date FDA Received: 03/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2019
• 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