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 05/18/2016

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by mfr: returned product consisted of a jetstream xc-2.1 atherectomy catheter in one piece.Visual inspection of the catheter shaft revealed no irregularities.During connection of the catheter pod to the console the connector had difficulty engaging into the console connector.Further examination of the connector revealed bent pins in the connector.Engineers from the research and development group as well as from the design assurance group also analyzed the issue with this complaint.Their findings were that the positive motor voltage pin #19, was bent and making continuous contact with the rex pin #8 and causing constant power to the rex function of the device which caused the rex rotation to stay active during the release of the rex button.Bent pins in the connector could give system errors that the customer experienced.Functional testing of the device could not be completed due to the damaged pins in the connector.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that the motor kept spinning with the activation button not depressed.A 2.1mm jetstream® xc atherectomy catheter was selected for an atherectomy procedure in the popliteal segment of the right leg.Upon activation of the jetstream device, the motor kept spinning with the activation button not depressed.The retraction (rex) button was attempted to remedy the issue; however, when depressed, it would not engage nor did it stop the forward (activation) spinning of the burr.Due to the inability to cease the burr from spinning, the console was electrically powered down while the catheter was in the body.Once powered down, the catheter was removed from the patient without incident.An attempt to re-prime the device was performed; however the device was not able to prime and at this time a pod error light appeared on the console.The procedure was completed with another of the same device.No patient complications were reported.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5734037
• MDR Text Key: 47701835
• Report Number: 2134265-2016-06029
• 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: 06/17/2016

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: 11/30/2017
• Device Model Number: 112264-001
• Device Catalogue Number: PV31300
• Device Lot Number: 18854644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2016
• Initial Date FDA Received: 06/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2016
• 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