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 12/01/2020

Event Type  malfunction  

Event Description

It was reported that there was a loss of rotation.A 2.4mm jetstream xc catheter was selected for an atherectomy procedure in the distal superficial femoral artery (sfa) and proximal popliteal segment.During the procedure, rotation slowed in a tight stenosis and then completely stopped rotating and continued to not rotate when it was in a larger vessel.No visible damage was observed on the catheter and no error message displayed.A new jetstream catheter was used to complete the procedure.There were no patient complications.

Event Description

It was reported that there was a loss of rotation.A 2.4mm jetstream xc catheter was selected for an atherectomy procedure in the distal superficial femoral artery (sfa) and proximal popliteal segment.During the procedure, rotation slowed in a tight stenosis and then completely stopped rotating and continued to not rotate when it was in a larger vessel.No visible damage was observed on the catheter and no error message displayed.A new jetstream catheter was used to complete the procedure.There were no patient complications.

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 was inspected for damage.Visual examination showed multiple bucklings from the tip to proximal 35cm on the shaft.A severe kink was also noticed 1cm from the tip.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.

• 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: 11012760
• MDR Text Key: 221808270
• Report Number: 2134265-2020-17824
• 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: 01/11/2021

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: 06/14/2022
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0025716337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 01/07/2021
• Supplement Dates FDA Received: 01/11/2021
• Patient Sequence Number: 1
• Patient Age: 75 YR