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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 Entrapment of Device (1212); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/06/2023
Event Type  malfunction  
Event Description
It was reported that the burr was stuck with the wire.The 80% stenosed target lesion was located in the mildly tortuous and moderately calcified mid left anterior descending artery (lad).A 1.50mm rotapro was selected for use.Rotablation was completed successfully, however, while in dynaglide mode for burr removal, the guidewire began meeting resistance and bringing the wire back with the burr.The burr was unable to be removed off the rotawire guidewire.The clinician stopped and used a workhorse wire to buddy wire down the lad.After vessel was secured with a workhorse wire, the rotawire guidewire and burr were removed as one.Upon removal, the wire could not be removed from the advancer.The advancer was disconnected at the handshake connection and the wire was not visible there either.The wire was removed from the burr with some force at a later time, this may have stretched the spring coiled section of the drive shaft of the burr.The procedure was completed with the original device.No patient complications were reported, and the patient was stable after procedure.
 
Manufacturer Narrative
E1 - initial reporter city: (b)(6).
 
Event Description
It was reported that the burr was stuck with the wire.The 80% stenosed target lesion was located in the mildly tortuous and moderately calcified mid left anterior descending artery (lad).A 1.50mm rotapro was selected for use.Rotablation was completed successfully, however, while in dynaglide mode for burr removal, the guidewire began meeting resistance and bringing the wire back with the burr.The burr was unable to be removed off the rotawire guidewire.The clinician stopped and used a workhorse wire to buddy wire down the lad.After vessel was secured with a workhorse wire, the rotawire guidewire and burr were removed as one.Upon removal, the wire could not be removed from the advancer.The advancer was disconnected at the handshake connection and the wire was not visible there either.The wire was removed from the burr with some force at a later time, this may have stretched the spring coiled section of the drive shaft of the burr.The procedure was completed with the original device.No patient complications were reported, and the patient was stable after procedure.
 
Manufacturer Narrative
E1 - initial reporter city: (b)(6).Device evaluated by mfr: the burr catheter from a rotapro device was returned for analysis.The rotapro advancer was not returned.The handshake connection, sheath, coil, burr and annulus were visually examined.Inspection of the device did not identify any damages or defects.The rotawire used in the procedure was returned and used for analysis.During testing, the wire was inserted through the annulus and was able to be fully advanced and removed from the device with no resistance or issues.
 
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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 Key18238395
MDR Text Key329381655
Report Number2124215-2023-63287
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729893356
UDI-Public8714729893356
Combination Product (y/n)N
Reporter Country CodeAS
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 01/03/2024
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 Number0031965032
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/07/2023
Initial Date FDA Received11/30/2023
Supplement Dates Manufacturer Received12/12/2023
Supplement Dates FDA Received01/03/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/07/2023
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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