MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTALINK PLUS; CATHETER, CORONARY, ATHERECTOMY

Model Number	3241
Medical Device Problem Codes	Unstable (1667); Output Problem (3005)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that unstable speed occurred.The target lesion was located in the moderately tortuous and severely calcified right coronary artery.A 2.25mm rotalink plus was selected for use.During preparation, when the speed was set at 180,000rpm, the set up was competed.During the procedure, at third ablation, it was noted that the rotation speed did not increase.The setting was checked again outside the patient, and the speed was noted to be unstable increasing and decreasing.It further did not increase.The procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that unstable speed occurred.The target lesion was located in the moderately tortuous and severely calcified right coronary artery.A 2.25mm rotalink plus was selected for use.During preparation, when the speed was set at 180,000rpm, the set up was competed.During the procedure, at third ablation, it was noted that the rotation speed did not increase.The setting was checked again outside the patient, and the speed was noted to be unstable increasing and decreasing.It further did not increase.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by mfr: the device was returned for analysis.The returned complaint device consisted of a rotablator rotalink plus device.The burr catheter was received attached to the advancer.The advancer, handshake connections, sheath, coil and burr were microscopically and visually examined.There are numerous sheath kinks.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 was not able to get any speed.The advancer was dismantled and the ultem was found to be melted and the turbine was corroded.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: ROTALINK PLUS
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8325621
• Report Number: 2134265-2019-01059
• Device Sequence Number: 16573446
• Product Code: MCX
• UDI-Device Identifier: 08714729228394
• UDI-Public: 08714729228394
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/16/2020
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0022804158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Initial Date Received by Manufacturer: 01/18/2019
• Supplement Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 03/14/2019
• Patient Sequence Number: 1