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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 39467-125
Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/03/2023
Event Type  malfunction  
Event Description
It was reported that the sheath leaked and a hole in the sheath occurred.A 1.25mm rotapro was selected for percutaneous coronary intervention (pci) procedure.During preparation, it was noted that there was a hole in the catheter near the burr and it was leaking fluid.The procedure was completed successfully and there were no patient complications reported.
 
Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of the rotapro atherectomy device.The advancer, drive shaft, handshake connections, sheath, coil, and burr were visually and microscopically examined.Inspection of the device found that the sheath was torn at 23cm distal of the burr housing strain relief.Functional testing was performed by connecting the rotapro device to the liquid infusion line.When liquid was advanced through the device, a leak was identified at the damaged portion of the sheath in accordance.Product analysis confirmed the reported event, as the sheath was damaged and leaking in accordance with the reported events.Inspection of the remainder of the device, revealed no other damage or irregularities.
 
Event Description
It was reported that the sheath leaked and a hole in the sheath occurred.A 1.25mm rotapro was selected for percutaneous coronary intervention (pci) procedure.During preparation, it was noted that there was a hole in the catheter near the burr and it was leaking fluid.The procedure was completed successfully and there were 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
EI  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key17379736
MDR Text Key319704987
Report Number2124215-2023-37151
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729893356
UDI-Public8714729893356
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P900056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/21/2023
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 Number39467-125
Device Catalogue Number39467-125
Device Lot Number0030634099
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/03/2023
Initial Date FDA Received07/24/2023
Supplement Dates Manufacturer Received08/01/2023
Supplement Dates FDA Received08/21/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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