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

Model Number 45007

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2020

Event Type  malfunction  

Event Description

It was reported that there was improper aspiration.A 2.1mm jetstream xc catheter was selected for an atherectomy procedure in the right superficial femoral artery (sfa).During priming, the device did not seem to be aspirating properly and had a lot of air in the system.The device was introduced into the patient and ran for 5 seconds where it still did not aspirate properly.There were no visual defects observed nor error messages displayed.A new jetstream device was used and the case was successfully completed.There were no patient complications reported and the patient was good post procedure.

Manufacturer Narrative

Device eval by manufacturer: the jetstream device xc-2.1 was received by boston scientific for analysis.The device was visually examined for any shaft damage and the functional testing of the device was completed.The device showed a kink located 81.5cm from the tip.Functional analysis was done by completing the setup procedure per the instructions for use.The device primed and the blades rotated as designed.Aspiration testing of the device was done per the test procedure.The device is tested by using a beaker of water.The device's tip is submerged in a beaker of fluid and the device is run for a period of 1 minute.Test results showed that this device did perform as designed per the test procedure specification.Inspection of the remainder of the device revealed no damage or irregularities.The complaint was not confirmed for evacuation issues.

Event Description

It was reported that there was improper aspiration.A 2.1mm jetstream xc catheter was selected for an atherectomy procedure in the right superficial femoral artery (sfa).During priming, the device did not seem to be aspirating properly and had a lot of air in the system.The device was introduced into the patient and ran for 5 seconds where it still did not aspirate properly.There were no visual defects observed nor error messages displayed.A new jetstream device was used and the case was successfully completed.There were no patient complications reported and the patient was good 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: 11012947
• MDR Text Key: 221810627
• Report Number: 2134265-2020-17830
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889892
• UDI-Public: 08714729889892
• 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: 01/12/2021

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2022
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0026132121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Date Manufacturer Received: 01/07/2021
• Patient Sequence Number: 1