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

Model Number H749236310020

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Event Description

Same case as mdr id: 2134265-2018-05116.It was reported that rotaburr speed was unstable.The target lesion was located in the severely calcified left anterior descending (lad) artery.A 1.25mm rotalink¿ plus and 1.50mm rotalink¿ plus were selected for use.During the procedure, after ablation was performed successfully using a 1.25mm rotalink¿ burr, a 1.50mm rotalink¿ burr was then used.The operational speed for the 1.50mm burr was set at 230,000rpm outside the patient's body; however, it was noted that the speed increased to 280,000rpm inside the patient's body.Consequently, the 1.50mm rotalink¿ burr was replaced with another 1.25mm rotalink¿ burr.However, it was noted that the same issue occurred wherein the rotational speed raised to and would not decrease from 280,000rpm inside the patient's body.The procedure was completed with a 1.75mm rotalink¿ burr.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The advancer, burr, sheath, coil, and handshake connections were microscopically and visually examined.The annulus of the burr was damaged and flared.Functional testing was performed by connecting the rotablator rotalink plus device to the rotablator control console system.There were no abnormal noises or leaks, as 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.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.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: ¿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¿.Also, it was reported that the speed was set-up at 230,000rpm and also ran at 200,000rpm.The rotablator dfu the following related to the set-up and operating speeds: ¿adjust the turbine pressure knob until the burr is spinning at the correct speed.1.25 ¿ 2.0mm burrs 190,000 rpm recheck the rotational speed reading to verify that the rotation rate is appropriate for the burr size and lesion type, and adjust the operating speed.1.25 ¿ 2.0mm burrs 160,000 up to 180,000 rpm¿.(b)(4).

Event Description

Same case as mdr id: 2134265-2018-05116.It was reported that rotaburr speed was unstable.The target lesion was located in the severely calcified left anterior descending (lad) artery.A 1.25mm rotalink plus and 1.50mm rotalink plus were selected for use.During the procedure, after ablation was performed successfully using a 1.25mm rotalink burr, a 1.50mm rotalink burr was then used.The operational speed for the 1.50mm burr was set at 230,000rpm outside the patient's body; however, it was noted that the speed increased to 280,000rpm inside the patient's body.Consequently, the 1.50mm rotalink burr was replaced with another 1.25mm rotalink burr.However, it was noted that the same issue occurred wherein the rotational speed raised to and would not decrease from 280,000rpm inside the patient's body.The procedure was completed with a 1.75mm rotalink burr.No patient complications were reported and the patient's status was stable.

• 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: 7579552
• MDR Text Key: 110457212
• Report Number: 2134265-2018-05359
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: 08714729316411
• 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,Followup
• Report Date: 05/18/2018

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: 12/30/2019
• Device Model Number: H749236310020
• Device Catalogue Number: 23631-002
• Device Lot Number: 21670397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2018
• Initial Date FDA Received: 06/07/2018
• Supplement Dates Manufacturer Received: 06/08/2018
• Supplement Dates FDA Received: 06/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2018
• 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