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

Model Number 45007

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: event date was not reported and was approximated to (b)(6) 2020.

Event Description

It was reported that the device stopped rotating.A 2.4mm jetstream xc catheter was selected for an atherectomy procedure in the right leg's superficial femoral artery.The device was used over a 0.014in thruway guidewire.Rotaglide atherectomy lubricant was also used.While advancing, the device kept stopping.No error message displayed and no visible defects were noted.The device stopped all activity and was removed.The procedure was completed with another jetstream xc catheter.No patient complications were reported and the patient did well post-procedure.

Event Description

It was reported that the device stopped rotating.A 2.4mm jetstream xc catheter was selected for an atherectomy procedure in the right leg's superficial femoral artery.The device was used over a 0.014in thruway guidewire.Rotaglide atherectomy lubricant was also used.While advancing, the device kept stopping.No error message displayed and no visible defects were noted.The device stopped all activity and was removed.The procedure was completed with another jetstream xc catheter.No patient complications were reported and the patient did well post-procedure.

Manufacturer Narrative

B3 date of event: event date was not reported and was approximated to (b)(6) 2020.Device eval by manufacturer: the jetstream device xc-2.4 was received by boston scientific for analysis.The shaft and the remainder of the device was inspected for damage.Visual examination showed 3 kinks located 1cm, 55cm and 57cm from the tip.The infusion lines were cut by the customer.The functionality of the device was checked by setting up the product per the instructions for use.The device primed.The device was activated, and the blades did not spin as designed.

• 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: 10678005
• MDR Text Key: 211303910
• Report Number: 2134265-2020-14157
• 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: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2021
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0024644743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Date Manufacturer Received: 11/03/2020
• Patient Sequence Number: 1
• Patient Age: 60 YR