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

Model Number	3241
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the speed was unstable.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified vessel.A 2.25mm rotalink plus was selected for use.During preparation, it was noted that the rotational speed was unstable; set operational speed was 190000 rpm.The procedure was completed with a different device.There were no patient complications reported.
Additional Manufacturer Narrative
E1.Initial reporter city: (b)(6).
Event or Problem Description
It was reported that the speed was unstable.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified vessel.A 2.25mm rotalink plus was selected for use.During preparation, it was noted that the rotational speed was unstable; set operational speed was 190000 rpm.The procedure was completed with a different device.There were no patient complications reported.It was further reported that the maximum speed reached was 190,000, which did not exceed the set operational speed.Also, there was no particular problem in the test but suddenly it switched to dynaglide during cutting in the body.The dynaglide was released and the cutting was repeated several times, but the dynaglide was switched to.

• 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: 9990316
• Report Number: 2134265-2020-05480
• Device Sequence Number: 17102794
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2020

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: 05/12/2021
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0023940862
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/09/2020
• Supplement Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 04/23/2020
• Supplement Report FDA Received Date: 06/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1