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	03/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).
Event or Problem Description
It was reported that unstable speed occurred.The target lesion was located in the coronary artery.A 2.25mm rotalink¿ plus was selected for use.During the procedure, it was noted that the rotation speed of the device was unstable.No patient complications reported and patient's status was good.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The advancer, coil, sheath, handshake connections, burr, and annulus were microscopically and visually examined.Functional testing was performed by connecting the advancer to the rotablator control console system.There were no abnormal noises or leaks and the device did not run; so it wasn¿t able to get any speed.The advancer was dismantled and the ultem was found to be melted and the turbine is corroded.Product analysis confirmed the reported event due to the melted ultem.The investigation conclusion is user / use error as there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user.The dfu states: ¿never operate the rotablator advancer without saline infusion.Flowing saline is essential for cooling and lubricating the working parts of the advancer.Operation of the advancer without proper saline infusion may result in permanent damage to the advancer¿.(b)(4).
Event or Problem Description
It was reported that unstable speed occurred.The target lesion was located in the coronary artery.A 2.25mm rotalink plus was selected for use.During the procedure, it was noted that the rotation speed of the device was unstable.No patient complications reported and patient's status was good.

• 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: 7408709
• Report Number: 2134265-2018-02985
• Device Sequence Number: 1121546
• Product Code: MCX
• UDI-Device Identifier: 08714729228394
• UDI-Public: 08714729228394
• 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,Followup
• Report Date (Section B): 03/20/2018

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: 06/03/2019
• Device Model Number: H749236310060
• Device Catalogue Number: 23631-006
• Device Lot Number: 20841976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Initial Date Received by Manufacturer: 03/20/2018
• Supplement Date Received by Manufacturer: 04/21/2018
• Initial Report FDA Received Date: 04/09/2018
• Supplement Report FDA Received Date: 05/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1