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

Model Number H749236310040

Device Problem Activation Problem (4042)

Patient Problem No Patient Involvement (2645)

Event Date 06/19/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of a rotablator rotalink plus device.The burr catheter was received attached to the advancer.The advancer is bloody, there is blood in the saline drip line and in the sheath.The sheath is torn/separated 33cm from the distal end of the sheath.The coil is slightly stretched and kinked at the handshake connection.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 was corroded.Blood was pooled in the motor housing.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.As per product dfu: ¿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 Description

Reportable based on device analysis completed on 18oct2018.It was reported that the device stalled.A 1.75mm rotalink¿ plus was selected for use.During preparation, it was noted that the rotation speed suddenly stopped as the stall lamp was on upon adjusting the rotational speed; the cocktail was flowing.The speed did not improve after that.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed that a sheath torn/separated.

• Brand Name: ROTALINK¿ PLUS
• Type of Device: CATHETER, CORONARY, 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: 8070137
• MDR Text Key: 127207975
• Report Number: 2134265-2018-07511
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729228370
• UDI-Public: 08714729228370
• Combination Product (y/n): N
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/18/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 12/22/2019
• Device Model Number: H749236310040
• Device Catalogue Number: 23631-004
• Device Lot Number: 0021638986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2018
• Initial Date FDA Received: 11/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2018
• 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