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

Model Number 112264-001

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.The most probable root cause was unable to be determined.(b)(4).

Event Description

Same case as: 2134265-2017-02273.It was reported that there was a loss of rotational speed.Two jetstream® xc atherectomy catheters were selected for an atherectomy procedure.While treating the unspecified lesion with the 2.4mm jetstream xc device, the motor ceased to function.The device was removed from the patient.A 2.1mm jetstream was selected for use; however shortly after starting, the device stopped.The case was completed with this device.There were no patient complications and the patient's condition was fine.

• 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: 6400980
• MDR Text Key: 69849591
• Report Number: 2134265-2017-02288
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2017

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 Model Number: 112264-001
• Device Catalogue Number: PV31300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2017
• Initial Date FDA Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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