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

Model Number H749236310040

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that erratic speeds occurred during preparation.A 1.75mm rotalink plus was selected for use.During preparation, it was noted that the rotational speed was erratically moving from 130,000rpms to over 200,000 rpms.All connections were checked; however, the problem remained.Eventually the speed dropped down and remained there.The rotalink plus was exchanged for another and the procedure was completed successfully.There were no patient complications.

Manufacturer Narrative

Device evaluated by manufacturer: device was returned for analysis.Returned product consisted of the rotablator rotalink plus device.The advancer unit and burr unit were received attached together as a single unit.The advancer knob was received tightened in a backward position.Based on the potential root causes identified in the fmea; the advancer, handshake connections, sheath, coil, and burr were microscopically and visually inspected.The annulus was damaged/not rounded.It is probable that the rotating burr came into contact with the guidewire during preparation leading to the damaged annulus.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 advancer was dismantled and the ultem was found to be extremely melted.The ultem was so melted that the drive shaft was unable to be removed and you can see melted plastic through the side hole of the ultem.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.No other issues were identified during the product analysis.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.1.25 ¿ 2.0 mm burrs 190,000 rpm¿ (b)(4).

Event Description

It was reported that erratic speeds occurred during preparation.A 1.75mm rotalink¿ plus was selected for use.During preparation, it was noted that the rotational speed was erratically moving from 130,000rpms to over 200,000 rpms.All connections were checked; however, the problem remained.Eventually the speed dropped down and remained there.The rotalink¿ plus was exchanged for another and the procedure was completed successfully.There were no patient complications.

• 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: 6199587
• MDR Text Key: 63219883
• Report Number: 2134265-2016-12029
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729228370
• UDI-Public: (01)08714729228370(17)20180630(10)0019533224
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2016

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: 06/30/2016
• Device Model Number: H749236310040
• Device Catalogue Number: 23631-004
• Device Lot Number: 0019533224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 12/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2016
• 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