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

Model Number H749236310050

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the speed was unstable.A 2.00mm rotalink¿ plus was selected for use.During preparation, outside the patient's body, the speed was adjusted to 180,000 rpm but it did not increase.Various connections were checked and the speed finally increased to 180,000rpm.However, it was also noted that the speed was unstable and might have exceeded 180,000rpm, reaching up to approximately185,000 rpm.The speed didn¿t rise extremely more than 10,000 rpm.When it was inserted into the patient, the device rotated by dynaglide mode and eventually it stopped rotating and the stall lamp turned on.The procedure was completed with another of the same catheter.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.Returned product consisted of the rotablator rotalink plus device.The advancer, burr, sheath, coil, and handshake connections were microscopically and visually examined.There was no damage or irregularities to the device.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 turbine was found to be corroded and the ultem was found to be melted.A melted ultem is due to the interruption of saline or by insufficient flow of saline used during the preparation or during the procedure of the device.Saline is used in the clinical setting to cool and lubricate the moving parts and prevents a melted ultem, ensuring the functional use of the device.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.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 Description

It was reported that the speed was unstable.A 2.00mm rotalink plus was selected for use.During preparation, outside the patient's body, the speed was adjusted to 180,000 rpm but it did not increase.Various connections were checked and the speed finally increased to 180,000rpm.However, it was also noted that the speed was unstable and might have exceeded 180,000rpm, reaching up to approximately185,000 rpm.The speed didn¿t rise extremely more than 10,000 rpm.When it was inserted into the patient, the device rotated by dynaglide mode and eventually it stopped rotating and the stall lamp turned on.The procedure was completed with another of the same catheter.No patient complications were reported.

• 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: 7664881
• MDR Text Key: 113288049
• Report Number: 2134265-2018-06329
• Device Sequence Number: 1
• Product Code: MCX
• 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
• Type of Report: Initial,Followup
• Report Date: 06/19/2018

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: 03/19/2020
• Device Model Number: H749236310050
• Device Catalogue Number: 23631-005
• Device Lot Number: 0022012787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Initial Date Manufacturer Received: 06/19/2018
• Initial Date FDA Received: 07/05/2018
• Supplement Dates Manufacturer Received: 07/20/2018
• Supplement Dates FDA Received: 08/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1