MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK ROTALINK¿ PLUS; CATHETER, CORONARY, ATHERECTOMY

Model Number	H749236310060
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The rotawire was damaged.The advancer unit and burr unit were received attached together as a single unit.The advancer knob was returned tightened in a backward position.Microscopic examination did not present any damage.Functional testing was performed by connecting the rotablator rotalink plus device to the rotablator control console system.The device was not able to get any speed and the stall light came on the console.The advancer was dismantled and the ultem was found to be melted.Inspection of the remainder of the device presented no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause has been determined to be use/user error as the dfu states: ¿adjust the turbine pressure knob until the burr is spinning at the correct speed.2.15mm burrs and larger 180,000 rpm¿ (b)(4).
Event or Problem Description
It was reported that unstable speed occurred.A 2.25mm rotalink¿ plus was selected for use.After setting up the device, the speed was set to 200kpm outside the patient.Then, the physician tried to deliver using dynaglide mode from the guiding catheter.However, the rotation speed did not stabilized and was not delivered.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

• Brand Name: ROTALINK¿ PLUS
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• MDR Report Key: 6456388
• Report Number: 2134265-2017-02624
• Device Sequence Number: 18974497
• Product Code: MCX
• UDI-Device Identifier: 08714729228394
• UDI-Public: (01)08714729228394(17)20180930(10)0019842640
• Combination Product (Y/N): N
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/13/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: H749236310060
• Device Catalogue Number: 23631-006
• Device Lot Number: 0019842640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2017
• Initial Report FDA Received Date: 04/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1