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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 Failure to Advance (2524); Communication or Transmission Problem (2896); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/05/2023
Event Type  Injury  
Event Description
It was reported that wire detachment occurred.A comet ii pressure guidewire was being used.During the procedure, it was reported that there was a possibility that excessive torque was applied when crossing the lesion.After obtaining the value in the first measurement for ischemia evaluation of the right coronary artery distal lesion, an attempt was made to perform a measurement for the second time, but there was no signal.During removal, separation occurred approximately 30 cm from the tip.The device was removed from the body along with the microcatheter when it was withdrawn, and no fragments remained inside the patient.The procedure was completed, and no further patient complications were reported.
 
Event Description
It was reported that wire detachment occurred.A comet ii pressure guidewire was being used.During the procedure, it was reported that there was a possibility that excessive torque was applied when crossing the lesion.After obtaining the value in the first measurement for ischemia evaluation of the right coronary artery distal lesion, an attempt was made to perform a measurement for the second time, but there was no signal.During removal, separation occurred approximately 30 cm from the tip.The device was removed from the body along with the microcatheter when it was withdrawn, and no fragments remained inside the patient.The procedure was completed, and no further patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an ffr comet pressure wire in two sections.The occ cable was not returned for analysis.The tip, device shaft, proximal face end, and sensor port were microscopically and visually examined for damage, or any irregularities.Inspection of the device revealed that there were numerous kinks throughout the body of the wire.The wire was separated 33cm proximal of the tip, at the second tri-cut.The separated/detached ends appeared to be bent and jagged, with coating peeled away for a length of.5mm on the proximal separated end.The damage to the separated ends indicates that the device was kinked, and pressure/torque was applied prior to separation.The appearance of the confirmed damage was consistent to damage that can be caused from interaction with another device or patient anatomy during the procedure when torquing the device in the lesion.As the device was separated, device to device testing could not be performed, so the sensor port was viewed to verify that the sensor was in the correct location.This sensor was visible and in the correct location within the sensor housing.The wire was gently shaken to see if the sensor would move and be more visible within the sensor housing.The sensor did not move which verified the sensor was not detached from the fiber optic cable.As the sensor was not detached, it was most likely that the kinking then separation caused internal fiber optic damage of the wire, causing the reported signal issue.No other issues were identified during the product analysis.
 
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Brand Name
COMET II
Type of Device
TRANSDUCER, PRESSURE, CATHETER TIP
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key17827719
MDR Text Key324397145
Report Number2124215-2023-52738
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 Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/17/2023
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 Number0031132064
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/05/2023
Initial Date FDA Received09/27/2023
Supplement Dates Manufacturer Received10/10/2023
Supplement Dates FDA Received10/17/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/27/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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