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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 Myocardial Infarction (1969); Vasoconstriction (2126); Foreign Body In Patient (2687)
Event Date 04/05/2021
Event Type  Death  
Event Description
It was reported that the rotaburr became stuck within the lesion, the rotaburr and rotawire were difficult to remove, the procedure was aborted, the patient went to surgery then later died during surgery. A 2. 00mm peripheral rotalink plus atherectomy catheter burr and a peripheral rotawire guidewire were selected for use in a tibial atherectomy procedure. The patient was being treated at an outpatient facility. The 100% stenosed target lesion was located in the mildly tortuous and severely calcified peroneal artery. The devices were advanced to the lesion and atherectomy was performed with a set rotational speed of 180,000rpm. The burr stalled and became lodged into the peroneal artery. The burr could not be removed from the peroneal artery. At the time the burr became stuck in the peroneal artery the patient experienced a vasospasm which may have played a role in the burr becoming stuck within the peroneal artery. The procedure was cancelled and the patient was transferred via an ambulance to the hospital to have the devices removed surgically. The peripheral rotawire guidewire was removed but the patient experienced a cardiac event including myocardial infarction. During the burr removal, the patient died. The burr was not recovered. There was no postmortem performed on the patient.
 
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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 CORK LIMITED
model farm road
cork
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key11726889
MDR Text Key247354141
Report Number2134265-2021-05019
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,Followup
Report Date 05/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number29720
Device Catalogue Number29720
Device Lot Number0026740024
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/28/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/02/2021
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: 04/26/2021 Patient Sequence Number: 1
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