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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 39467-200
Device Problems Output Problem (3005); Noise, Audible (3273); Intermittent Loss of Power (4016)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/23/2023
Event Type  malfunction  
Manufacturer Narrative
E1.Initial reporter address 1: (b)(6).
 
Event Description
It was reported that the procedure was cancelled.A 2.00mm rotapro was selected for use.During the procedure, 3 rotapro advancers were used.First, a 1.5mm rotapro was used to ablate the lesion without any problem.Second, a 2.0mm rotapro was checked outside the body, but an abnormal sound was noticed, and red stall was displayed upon advancing inside the patient in dynaglide mode; the speed did not increase.Therefore, the rotawire and advancer were replaced.The third 2.0mm rotapro was checked but has the same issue with the second one, rota was then stopped.
 
Event Description
It was reported that the procedure was cancelled.A 2.00mm rotapro was selected for use.During the procedure, 3 rotapro advancers were used.First, a 1.5mm rotapro was used to ablate the lesion without any problem.Second, a 2.0mm rotapro was checked outside the body, but an abnormal sound was noticed, and red stall was displayed upon advancing inside the patient in dynaglide mode; the speed did not increase.Therefore, the rotawire and advancer were replaced.The third 2.0mm rotapro was checked but has the same issue with the second one, rota was then stopped.
 
Manufacturer Narrative
E1.Initial reporter address 1: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection of the device did not identify any damages or defects.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 stalled and would not run.In order to determine the cause for the device stall, destructive testing was performed, in which the advancer was dismantled, and the interior components were inspected for damages or defects.During destructive testing, it was identified that dried saline was present on the shutter and rotor of the device.It was considered likely that the presence of dried saline interfered with the devices ability to rotate or to communicate rpm to the console using the fiber optic cable, leading to a device stall.
 
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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 SCIMED, INC
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 Key17758898
MDR Text Key323552430
Report Number2124215-2023-47783
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729893356
UDI-Public8714729893356
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P900056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/30/2023
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 Number39467-200
Device Catalogue Number39467-200
Device Lot Number0031329113
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/23/2023
Initial Date FDA Received09/15/2023
Supplement Dates Manufacturer Received10/13/2023
Supplement Dates FDA Received10/30/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/29/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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