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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTALINK PLUS; CATHETER, CORONARY, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION ROTALINK PLUS; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number 3241
Medical Device Problem Code Output Problem (3005)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/01/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Date of event: used (b)(6) 2021 as no information was provided.(b)(6).
 
Event or Problem Description
It was reported that the rotation speed was not stable.A 1.75mm rotalink plus was selected for use.During the procedure, it was noted that the rotation speed was not stable.The procedure was completed with a different device.No complications were reported and there was no patient injury.
 
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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 Key11214575
Report Number2134265-2021-00632
Device Sequence Number17148288
Product Code MCX
UDI-Device Identifier08714729228370
UDI-Public08714729228370
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
P900056
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/22/2021
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 Date01/19/2021
Device Model Number3241
Device Catalogue Number3241
Device Lot Number0023365790
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/15/2021
Initial Report FDA Received Date01/22/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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