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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 Problems Entrapment of Device (1212); Intermittent Loss of Power (4016)
Patient Problems Pain (1994); Insufficient Information (4580)
Event Date 03/04/2021
Event Type  Injury  
Event Description
It was reported that burr stuck in lesion and open surgery was performed. The target lesion was located in the moderately calcified right posterior tibial artery. A 1. 50mm peripheral rotalink plus was selected for use. During procedure, the burr was advanced however it stalled and the patient was in pain. The device was then removed but it only came back at about 3-4cm before getting stuck. Attempts were made to remove the device by using dynaglide, manually pulling back. They even cut the burr off the advancer and used 6fr guide catheter to dislodge the burr from the vessel wall but was unsuccessful. The procedure was then stopped, patient was transferred to the nearby hospital and had an open surgery. The burr was removed and there were perforation seen as it was surrounded by the intimal wall and the patient was doing well post operation. No further patient complications reported.
 
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Brand NamePERIPHERAL ROTALINK PLUS
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
model farm road
cork
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key11569103
MDR Text Key242265577
Report Number2134265-2021-03739
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121774
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 03/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number29720
Device Catalogue Number29720
Device Lot Number0026414410
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/24/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/25/2021 Patient Sequence Number: 1
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