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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 Codes Entrapment of Device (1212); Mechanical Problem (1384)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/25/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the burr became stuck on the guide wire.A 1.50 mm peripheral rotalink plus and rotawire were selected for use in the anterior tibial.During the procedure after most of the procedure was completed, it was noted that burr stopped spinning on the rotawire and became stuck on the rotawire.It took a little bit of time to remove from the patient's body.The procedure was completed with another of the same device.No patient complications were reported.The patient was fine post procedure.
 
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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 Key8910934
Report Number2134265-2019-09917
Device Sequence Number1746475
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 Physician
Type of Report Initial
Report Date (Section B) 08/20/2019
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 Date05/02/2021
Device Model Number29720
Device Catalogue Number29720
Device Lot Number0023737257
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/25/2019
Initial Report FDA Received Date08/20/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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