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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
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/17/2019
Event Type  malfunction  
Event Description
It was reported that the shaft was broken.A 1.50mm rotalink plus was selected for use.During procedure, it was noted that the burr catheter shaft broke and was filled with blood.The burr was then removed from the patient's body without dynaglide and it was confirmed that there were no device fragments left inside the patient.The procedure was completed with another of the same device.No complications were reported and the patient is stable.
 
Manufacturer Narrative
Device evaluated by the manufacturer.The device was returned for analysis.The burr catheter was received attached to the advancer unit, the burr catheter housing was received dismantled.The advancer, handshake connections, sheath and coil were microscopically and visually examined.There are numerous sheath kinks.The sheath is kinked and torn at the burr catheter housing.The coil is stretched.Inspection of the remainder of the device presented no other damage or irregularities.
 
Event Description
It was reported that the shaft was broken.A 1.50mm rotalink plus was selected for use.During procedure, it was noted that the burr catheter shaft broke and was filled with blood.The burr was then removed from the patient's body without dynaglide and it was confirmed that there were no device fragments left inside the patient.The procedure was completed with another of the same device.No complications were reported and the patient is stable.
 
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Brand Name
ROTALINK PLUS
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8691319
MDR Text Key147731046
Report Number2134265-2019-06774
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729228363
UDI-Public08714729228363
Combination Product (y/n)N
PMA/PMN Number
P900056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/29/2019
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
Device Operator Health Professional
Device Expiration Date02/17/2021
Device Model Number3241
Device Catalogue Number3241
Device Lot Number0023511912
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/13/2019
Initial Date Manufacturer Received 05/21/2019
Initial Date FDA Received06/12/2019
Supplement Dates Manufacturer Received07/08/2019
Supplement Dates FDA Received07/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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