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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); Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/07/2022
Event Type  malfunction  
Event Description
It was reported that the burr was difficult to remove and was stuck on the rotawire. The target lesion was located in the mildly tortuous and mildly calcified tibial artery. A 1. 25mm peripheral rotalink plus and a rotawire were selected for use. During the procedure, it was noted that the burr was not easy to advance and retract. Consequently, the device was pulled out using dynaglide mode and made sure that the rotawire was not kinked and the rotaglide was dripping. The device was removed with the wire stuck in the catheter. The procedure was completed with a non boston scientific device. No patient complications were 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 CORK LIMITED
model farm road
cork
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13534298
MDR Text Key285626358
Report Number2134265-2022-01597
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/22/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number29720
Device Catalogue Number29720
Device Lot Number0027235153
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/30/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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