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

Model Number H80222782001A0

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 06/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Same case as mdr id: 2134265-2018-06260.It was reported that the speed was unstable.A rotalink¿ advancer and a rotablator console were selected for use.During preparation, the cables were connected respectively to the console and the compressed air pressure is evaluated at 100 psi.Then, the physician introduced the rotawire to the proximal end of the 1.50mm rotalink¿ burr and advancer already mounted obtaining it in its back.The draw test then was realized; however, it was noted that the burr rotates in fluctuating revolutions.The set operational speed was at 150,000 rpms but it went from 220,000 to 120,000 in less than 3 seconds with the pedal fully depressed.Also, the sound of revolutions was unusual from the advancer.It was assessed that everything was well connected with the required pressure so the physician tried again obtaining the same results.Physician decided to remove the rotaburr and disconnected the advancer from the rotalink burr.It was then noted that the rotalink burr was slightly bent in a segment proximal the handshake connection.The procedure was completed with a 1.75mm rotalink¿ plus.No patient complications were reported and patient's status was stable.

Event Description

Same case as mdr id: 2134265-2018-06260.It was reported that the speed was unstable.A rotalink advancer and a rotablator console were selected for use.During preparation, the cables were connected respectively to the console and the compressed air pressure is evaluated at 100 psi.Then, the physician introduced the rotawire to the proximal end of the 1.50mm rotalink burr and advancer already mounted obtaining it in its back.The draw test then was realized; however, it was noted that the burr rotates in fluctuating revolutions.The set operational speed was at 150,000 rpms but it went from 220,000 to 120,000 in less than 3 seconds with the pedal fully depressed.Also, the sound of revolutions was unusual from the advancer.It was assessed that everything was well connected with the required pressure so the physician tried again obtaining the same results.Physician decided to remove the rotaburr and disconnected the advancer from the rotalink burr.It was then noted that the rotalink burr was slightly bent in a segment proximal the handshake connection.The procedure was completed with a 1.75mm rotalink plus.No patient complications were reported and patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.Returned product consisted of a rotalink advancer.The advancer and handshake connections were microscopically and visually examined.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 is corroded.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 presented 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.The 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).

• Brand Name: ROTALINK¿ ADVANCER
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• MDR Report Key: 7664114
• MDR Text Key: 113288547
• Report Number: 2134265-2018-06499
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729317739
• UDI-Public: 08714729317739
• 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: 06/14/2018

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: 01/04/2020
• Device Model Number: H80222782001A0
• Device Catalogue Number: 22782-001A
• Device Lot Number: 0021698450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Initial Date Manufacturer Received: 06/14/2018
• 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
• Patient Age: 71 YR