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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAPRO; CATHETER, CORONARY, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION ROTAPRO; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number 39467-150
Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005); Intermittent Loss of Power (4016)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/07/2024
Event Type  malfunction  
Event Description
It was reported that a burr detachment occurred.A 1.50mm rotapro was selected for use for a chronic total occlusion (cto) procedure.During rotablation with the rotapro 1.50mm, the burr of the device stopped, and system stalled, and a stall alarm was noted.A second attempt was made, but the burr stopped again.Upon retraction, the rotapro burr became detached from the system.The system was retrieved.The procedure was completed with a different device.No patient complications were reported.
 
Manufacturer Narrative
E1: initial reporter phone: (b)(6).
 
Manufacturer Narrative
E1: initial reporter phone: (b)(6).Device evaluated by manufacturer: returned product consisted of the rotapro atherectomy device.The device was received with the burr separated.The rotawire used in the procedure was also returned.The burr was received on the returned rotawire.The advancer, drive shaft, handshake connections, housing, sheath, coil, and burr were visually and microscopically examined.Inspection of the device found that the coil had been stretched at the point of detachment from the burr and that the burr was detached from the coil.Functional testing was performed by attempting to rotate the drive shaft, and the drive shaft was able to be rotated.When the rotapro advancer was connected to the rotapro console control system and the knob switch [ablation button] was pressed, the device reached and maintained optimal rpm with no resistance or issues.Product analysis confirmed the reported detachment.The reported rotational speed issues were not able to be confirmed, as the device reached and maintained optimal rpm during analysis and clinical circumstances were not able to be replicated.
 
Event Description
It was reported that a burr detachment occurred.A 1.50mm rotapro was selected for use for a chronic total occlusion (cto) procedure.During rotablation with the rotapro 1.50mm, the burr of the device stopped, and system stalled, and a stall alarm was noted.A second attempt was made, but the burr stopped again.Upon retraction, the rotapro burr became detached from the system.The system was retrieved.The procedure was completed with a different device.No patient complications were reported.
 
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Brand Name
ROTAPRO
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
model farm road
cork T12 Y K88
EI   T12 YK88
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18783495
MDR Text Key336306501
Report Number2124215-2024-08840
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729893356
UDI-Public8714729893356
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/03/2024
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 Model Number39467-150
Device Catalogue Number39467-150
Device Lot Number0032242657
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/07/2024
Initial Date FDA Received02/26/2024
Supplement Dates Manufacturer Received03/13/2024
Supplement Dates FDA Received04/03/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/18/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ROTAWIREDRIVE EXTRA SUPPORT; ROTAWIREDRIVE EXTRA SUPPORT
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