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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COMET II; TRANSDUCER, PRESSURE, CATHETER TIP
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BOSTON SCIENTIFIC CORPORATION COMET II; TRANSDUCER, PRESSURE, CATHETER TIP Back to Search Results
Model Number 2404-03
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/11/2022
Event Type  malfunction  
Event Description
It was reported that distal tip fracture occurred.Vascular access was obtained via the left radial artery.The 75% stenosed target lesion was located in the moderately tortuous and mildly calcified coronary artery.A comet ii pressure guidewire was used in a coronary angiogram procedure.Upon unpacking, the comet ii was noted to be deformed and was felt that it was already broken.However, since there was no external damage, the comet ii was continued to be used and equalized in the body of the patient.During the wiring of the lesion the comet ii fractured but remained in one piece.The comet ii was removed without any residue left in the patient.The procedure was completed with another of the same device.No patient complications were reported.
 
Manufacturer Narrative
The device was returned for analysis.Returned product consisted of an ffr comet pressure wire.The occ cable was not returned for analysis.The occ cable, tip, and device shaft were visually and microscopically examined for damage or any irregularities.Inspection of the device revealed that the tip was stretched and partially detached at the proximal end where it meets the sensor housing.The appearance of the confirmed tip damage is consistent to damage that can be caused from interaction with handling the device during unpackaging or preparation or can be caused from interaction with another device or patient anatomy during the procedure.As the occ cable was not returned for analysis, a test occ cable was used for device-to-device testing.The proximal end of the wire was inserted into the handle of the occ cable.The shroud of the occ cable was then connected to the ffr link to verify the signal strength.The signal was present and the "signal strength" and "zeroed" showed green lights, as designed.The occ cable was then connected to the bench top testing equipment.The modulation was 14.3% and the coefficient values were confirmed to be programmed.
 
Event Description
It was reported that distal tip fracture occurred.Vascular access was obtained via the left radial artery.The 75% stenosed target lesion was located in the moderately tortuous and mildly calcified coronary artery.A comet ii pressure guidewire was used in a coronary angiogram procedure.Upon unpacking, the comet ii was noted to be deformed and was felt that it was already broken.However, since there was no external damage, the comet ii was continued to be used and equalized in the body of the patient.During the wiring of the lesion the comet ii fractured but remained in one piece.The comet ii was removed without any residue left in the patient.The procedure was completed with another of the same device.No patient complications were reported.
 
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Brand Name
COMET II
Type of Device
TRANSDUCER, PRESSURE, CATHETER TIP
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15698720
MDR Text Key305378888
Report Number2124215-2022-43177
Device Sequence Number1
Product Code DXO
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 11/08/2022
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 Number2404-03
Device Catalogue Number2404-03
Device Lot Number0029554696
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/11/2022
Initial Date FDA Received10/31/2022
Supplement Dates Manufacturer Received11/01/2022
Supplement Dates FDA Received11/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/08/2022
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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