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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERIPHERAL ROTALINK PLUS; CATHETER, PERIPHERAL, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION PERIPHERAL ROTALINK PLUS; CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 29720
Medical Device Problem Code Entrapment of Device (1212)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/01/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the burr became stuck on the wire.A 1.50mm peripheral rotalink plus and a rotawire were selected for use.During procedure, it was noted that the burr became stuck on the wire and would not advance.The rotalink plus burr was removed with the rotawire.The procedure proceeded with angioplasty with a different device.No patient complications were reported.
 
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Brand Name
PERIPHERAL ROTALINK PLUS
Common Device Name
CATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9262929
Report Number2134265-2019-13215
Device Sequence Number17061756
Product Code MCW
UDI-Device Identifier08714729838906
UDI-Public08714729838906
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K121774
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 10/31/2019
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 Date06/11/2021
Device Model Number29720
Device Catalogue Number29720
Device Lot Number0023940635
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/10/2019
Initial Report FDA Received Date10/31/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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