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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
Device Problem Detachment of Device or Device Component (2907)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Date 02/01/2020
Event Type  Injury  
Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2020 as no event date was reported.
 
Event Description
It was reported that the rotalink burr tip broke.A 1.25mm rotalink plus was selected for use.During the procedure, it was noted that the rotalink burr tip broke and was retrieved from the patient's body.No patient complications were reported.
 
Manufacturer Narrative
B3 date of event: date of event was approximated to(b)(6)2020 as no event date was reported.
 
Event Description
It was reported that the rotalink burr tip broke.A 1.25mm rotalink plus was selected for use.During the procedure, it was noted that the rotalink burr tip broke and was retrieved from the patient's body.No patient complications were reported.It was further reported that the device was used in the lower extremities and was successfully removed from the patient's body using a snare.Furthermore, proper closure device was used on patient and patient was discharged as per facility protocol.
 
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Brand Name
PERIPHERAL ROTALINK PLUS
Type of Device
CATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9799955
MDR Text Key182424677
Report Number2134265-2020-02696
Device Sequence Number1
Product Code MCW
UDI-Device Identifier08714729857808
UDI-Public08714729857808
Combination Product (y/n)N
PMA/PMN Number
K121774
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/27/2021
Device Model Number29720
Device Catalogue Number29720
Device Lot Number0023859775
Was Device Available for Evaluation? No
Date Manufacturer Received03/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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