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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 Problems Entrapment of Device (1212); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/09/2023
Event Type  Injury  
Event Description
It was reported that device entrapment occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified atrioventricular branch.A fractional flow reserve procedure was performed using a comet ii pressure guidewire.During the procedure, the patient sneezed causing the impermeable part of the tip to be trapped in a small peripheral blood vessel.The detached tip was successfully retrieved by using a microcatheter.The wire was deformed and stretched when it was pulled out.The procedure was completed with another of the same device.No patient complications were reported, and the patient had no problems following the procedure.
 
Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.Returned product consisted of an ffr comet pressure wire.The occ cable was not returned for analysis.The tip and device shaft were visually and microscopically examined for damage or any irregularities.Inspection of the device revealed that the tip was bent and stretched 6.5cm in length.The tip was also partially separated/detached approximately 2.5cm proximal of the proximal end of the tip (no pieces were missing as the separated ends were still intact to the stretched wire) due to the stretching.The appearance of the confirmed tip damage is consistent to damage that can be caused from interaction with another device or patient anatomy during the procedure.
 
Event Description
It was reported that device entrapment occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified atrioventricular branch.A fractional flow reserve procedure was performed using a comet ii pressure guidewire.During the procedure, the patient sneezed causing the impermeable part of the tip to be trapped in a small peripheral blood vessel.The detached tip was successfully retrieved by using a microcatheter.The wire was deformed and stretched when it was pulled out.The procedure was completed with another of the same device.No patient complications were reported, and the patient had no problems following the procedure.
 
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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 Key16477867
MDR Text Key310601198
Report Number2124215-2023-09866
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
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/24/2023
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 Number2404-03
Device Catalogue Number2404-03
Device Lot Number0030436115
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/21/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/09/2023
Initial Date FDA Received03/03/2023
Supplement Dates Manufacturer Received03/03/2023
Supplement Dates FDA Received03/24/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/27/2022
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) Other;
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