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

Model Number 45007

Device Problems Mechanical Problem (1384); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2020

Event Type  malfunction  

Event Description

It was reported that there was a loss of rotation.A 2.4mm jetstream xc was selected for an atherectomy procedure in the right superficial femoral artery.The catheter was prepped and set up.While in the body during the first pass, the sound changed and the catheter stopped spinning in blades down mode.The catheter was removed from the body and the procedure was completed with a second device.There were no patient complications and the patient was stable post procedure.

Manufacturer Narrative

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 were inspected for damage.Visual examination showed no damage on the shaft.The functionality of the device was checked by setting up the product per the instructions for use.The device primed as designed.The device was activated, and the blades did spin as designed.The device was functionally tested for a period of 2 minutes with no issues or errors in the blades down and blades up modes.Inspection of the remainder of the device revealed no damage or irregularities.

Event Description

It was reported that there was a loss of rotation.A 2.4mm jetstream xc was selected for an atherectomy procedure in the right superficial femoral artery.The catheter was prepped and set up.While in the body during the first pass, the sound changed and the catheter stopped spinning in blades down mode.The catheter was removed from the body and the procedure was completed with a second device.There were no patient complications and the patient was stable post procedure.

• 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: 10809454
• MDR Text Key: 215300295
• Report Number: 2134265-2020-15527
• 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: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2021
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0024570151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Date Manufacturer Received: 12/10/2020
• Patient Sequence Number: 1
• Patient Age: 74 YR