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

Model Number H749236310030

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: 2134265-2018-05359.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 mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by manufacturer: the device was returned for analysis.The advancer, coil, sheath, handshake connections, burr, and annulus were microscopically and visually examined.The annulus is damaged/not round.The coil is stretched.Functional testing was performed by connecting the advancer to the rotablator control console system.The device leaked from the sheath at the strain relief.The burr catheter housing was taken apart and the sheath was found to be separated/torn 55mm from the proximal end of the sheath.There is excessive wear on the sheath.There were no abnormal noises 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.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

Same case as mdr id: 2134265-2018-05359.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
• MDR Report Key: 7579551
• MDR Text Key: 110457049
• Report Number: 2134265-2018-05116
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729228363
• UDI-Public: 08714729228363
• 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
• 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: 01/02/2020
• Device Model Number: H749236310030
• Device Catalogue Number: 23631-003
• Device Lot Number: 0021691061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Initial Date Manufacturer Received: 05/18/2018
• Initial Date FDA Received: 06/07/2018
• Supplement Dates Manufacturer Received: 06/07/2018
• Supplement Dates FDA Received: 06/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1