MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE JETSTREAM® XC ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number 112266-003

Device Problems Electrical /Electronic Property Problem (1198); Aspiration Issue (2883)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/08/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Event Description

It was reported that there was a short circuit and the device stopped all activity.A 2.4mm jetstream xc atherectomy catheter was selected for an antegrade atherectomy procedure in the middle superficial femoral artery (sfa).The physician prepared the system correctly, the device was primed and atherectomy was activated for one second; however a "short circuit" occurred and the device stopped working.The procedure was completed with another of the same jetstream catheter.There were no patient complications.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a jetstream xc-2.4 atherectomy catheter.The shaft and the remainder of the device were inspected for damage.No damage was notice on the catheter shaft or the pod.The device was set up per the dfu and the device functioned as designed with no issues.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

Event Description

It was reported that there was a short circuit and the device stopped all activity.A 2.4mm jetstream xc atherectomy catheter was selected for an antegrade atherectomy procedure in the middle superficial femoral artery (sfa).The physician prepared the system correctly, the device was primed and atherectomy was activated for one second; however a "short circuit" occurred and the device stopped working.The procedure was completed with another of the same jetstream catheter.There were no patient complications.

• Brand Name: JETSTREAM® XC ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7382168
• MDR Text Key: 103933712
• Report Number: 2134265-2018-02811
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• PMA/PMN Number: K130637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 112266-003
• Device Catalogue Number: PV41340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1