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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 Problem Material Integrity Problem (2978)
Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001)
Event Date 11/17/2022
Event Type  Injury  
Event Description
It was reported that a wire fracture and coronary artery perforation occurred, requiring surgery.The target lesion was located in the coronary artery.A rotawire drive and 1.50mm rotapro were selected for use.During the delivery in dynaglide mode, ablation was performed in the target lesion 11 times at 15 seconds.During a subsequent ablation, it was confirmed in the imaging that the coronary artery ruptured, without noticing that the rotawire was separated.Due to the damage to the rotawire, the delivery of a non-boston scientific device was not possible and bleeding could not be ceased.The patient was sent to the operating room and pericardial drainage was performed.No further complications were reported.
 
Event Description
It was reported that a wire fracture and coronary artery perforation occurred, requiring surgery.The target lesion was located in the coronary artery.A rotawire drive and 1.50mm rotapro were selected for use.During the delivery in dynaglide mode, ablation was performed in the target lesion 11 times at 15 seconds.During a subsequent ablation, it was confirmed in the imaging that the coronary artery ruptured, without noticing that the rotawire was separated.Due to the damage to the rotawire, the delivery of a non-boston scientific device was not possible and bleeding could not be ceased.The patient was sent to the operating room and pericardial drainage was performed.No further complications were reported.It was further reported that the patient is still hospitalized.
 
Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The device was received in three sections.The advancer, drive shaft, and handshake connection were visually and microscopically examined.Inspection of the device found that the annulus was damaged.During inspection, the damage was found to be most likely attributable to continuous interaction between the annulus and rotawire during rotation.Testing was performed using the returned sections of the rotawire.During testing, the sections of the returned rotawire were not able to be inserted beyond the damaged annulus.Product analysis confirmed the reported rotawire fracture, as the annulus was damaged in a way resembling continuous interaction between the rotawire and rotating burr.
 
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Brand Name
ROTAPRO
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC SCIMED, INC
model farm road
cork
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15959137
MDR Text Key305256194
Report Number2124215-2022-51683
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729893356
UDI-Public8714729893356
Combination Product (y/n)N
Reporter Country CodeJA
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 01/03/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number39467-150
Device Catalogue Number39467-150
Device Lot Number0030097597
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/18/2022
Initial Date FDA Received12/12/2022
Supplement Dates Manufacturer Received12/13/2022
Supplement Dates FDA Received01/03/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/07/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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