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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 39467-175
Device Problems Entrapment of Device (1212); Failure to Advance (2524)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/08/2023
Event Type  malfunction  
Manufacturer Narrative
E1.Initial reporter address (b)(6).
 
Event Description
It was reported that the burr was stuck on the wire.The target lesion was located in the non-tortuous and non-calcified artery.A 1.75mm rotapro and a rotawire drive were selected for use.During the procedure while advancing the guidewire to position in the lesion, resistance was noted in the distal part of the guide catheter, preventing movement forward.The whole system was removed, and it was found that the rotawire was stuck in the rotapro.The devices were removed with traction and the procedure was completed with a 1.5mm rotapro and a rotawire floppy.No patient complications reported.
 
Manufacturer Narrative
E1.Initial reporter address 1- (b)(6).Device evaluated by mfr: the device was returned for evaluation.The advancer, drive shaft, and handshake connection were visually examined.Inspection of the device did not identify any damages or defects.Functional testing was performed with a test rotawire, as the rotawire used during the procedure was not returned for analysis.During functional testing, the rotawire was able to be fully inserted and removed with no resistance or issues.As the guide catheter used in the procedure was not returned for analysis, a test 7f mach1 guide catheter was used for functional testing per the guide catheter sizing chart within the instructions for use.The burr was inserted into the hub of the guide catheter and advanced through the guide catheter with no resistance or issues.
 
Event Description
It was reported that the burr was stuck on the wire.The target lesion was located in the non-tortuous and non-calcified artery.A 1.75mm rotapro and a rotawire drive were selected for use.During the procedure while advancing the guidewire to position in the lesion, resistance was noted in the distal part of the guide catheter, preventing movement forward.The whole system was removed, and it was found that the rotawire was stuck in the rotapro.The devices were removed with traction and the procedure was completed with a 1.5mm rotapro and a rotawire floppy.No patient complications 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 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 Key17800231
MDR Text Key324063960
Report Number2124215-2023-51323
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729893356
UDI-Public8714729893356
Combination Product (y/n)N
Reporter Country CodeCI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number39467-175
Device Catalogue Number39467-175
Device Lot Number0030739565
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/14/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/19/2022
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
GUIDECATHETER-7FR EBU4; GUIDECATHETER-7FR EBU4
Patient SexMale
Patient RaceWhite
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