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

Model Number 45007

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Embolism (1829)

Event Date 09/29/2020

Event Type  Injury  

Event Description

It was reported that a distal embolism occurred.A 2.4mm jetstream xc atherectomy catheter was used with a filter device in a peripheral atherectomy procedure.After using the jetstream, the patient had a distal embolization.The patient fully recovered and the procedure was successfully completed.

Event Description

It was reported that a distal embolism occurred.A 2.4mm jetstream xc atherectomy catheter was used with a filter device in a peripheral atherectomy procedure.After using the jetstream, the patient had a distal embolization.The patient fully recovered and the procedure was successfully completed.It was further reported the device was used in an atherectomy procedure within the right superficial femoral artery (sfa).A non-boston scientific filter device was used.There were no performance issues with the jetstream.The physician's opinion was that the jetstream may have contributed to the embolism and the filter may not have captured all particulates that were generated during atherectomy.

Event Description

It was reported that a distal embolism occurred.A 2.4mm jetstream xc atherectomy catheter was used with a filter device in a peripheral atherectomy procedure.After using the jetstream, the patient had a distal embolization.The patient fully recovered and the procedure was successfully completed.It was further reported the device was used in an atherectomy procedure within the right superficial femoral artery (sfa).A non-boston scientific filter device was used.There were no performance issues with the jetstream.The physician's opinion was that the jetstream may have contributed to the embolism and the filter may not have captured all particulates that were generated during atherectomy.It was further reported that additional intervention occurred to resolve the embolism.

• Brand Name: JETSTREAM XC ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11013296
• MDR Text Key: 221726369
• Report Number: 2134265-2020-17838
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2022
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0025518093
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2020
• Patient Sequence Number: 1
• Treatment: NAV 6 EMBOSHEILD, ABBOTT; NAV 6 EMBOSHEILD, ABBOTT
• Patient Outcome(s): Other; Required Intervention