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

Model Number 112266-001

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: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as: 2134265-2017-02288.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.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a jetstream xc-2.4 atherectomy catheter in one piece.Visual inspection of the device revealed that it was missing components when returned from customer.The device was inspected for damage.Visual examination noticed that the aspiration/infusion baton was severed from the pod.Due to the extreme damage to the device functional testing could not completed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

Same case as: 2134265-2017-02288.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 - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6400976
• MDR Text Key: 69847588
• Report Number: 2134265-2017-02273
• 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,Followup
• Report Date: 02/21/2017

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 Expiration Date: 12/31/2018
• Device Model Number: 112266-001
• Device Catalogue Number: PV41340
• Device Lot Number: 20194297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2017
• Initial Date FDA Received: 03/13/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2017
• 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