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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COMET; TRANSDUCER, PRESSURE, CATHETER TIP
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BOSTON SCIENTIFIC CORPORATION COMET; TRANSDUCER, PRESSURE, CATHETER TIP Back to Search Results
Model Number 8900
Device Problem Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/19/2020
Event Type  malfunction  
Event Description
It was reported that a coating issue occurred.The target lesion was located in the left anterior descending artery (lad).A comet pressure guidewire was advanced and a normal ffr was performed in the lad and the device was removed.While advancing into the right coronary artery (rca), a black damaged part was noticed to be adhered to the physicians gloves.It was noted that the black material was likely the comet coating.It was additionally noted that it was possible that the interaction with an inserter contributed to the issue, but the exact cause was unknown.The black material did not enter the patient.The procedure was completed with another of the same device.No patient complications were reported in relation to this event and the patient condition was good following the procedure.
 
Manufacturer Narrative
Device evaluated by mfr: the tip, device shaft, sensor port and the coefficient values were examined for damage or any irregularities.The devices shaft showed 1 kink located 46cm from the tip.There was some peeled coating notice at the 46cm location.The tip showed bends.The occ handle was connected to the ffr link to verify the signal strength.The signal was present as designed.The occ handle was then connected to the bench top testing equipment and the wire was inserted into the pressure chamber.The pressure was increased to verify the sensor was indeed reacting to the pressure increases and decreases.The pressure sensor functioned as designed.The coefficient values were confirmed to be programmed.The occ handle was again connected to the ffr link.The device was then connected to the polaris (ilab) test equipment via bluetooth signal.The wire communicated to the polaris system and zeroed as designed.The wire was inserted into the test pressure chamber and the wire transferred a pressure waveform to the polaris which indicates a functioning wire.The wire was removed from the occ handle with no issues.The sensor port showed no residue of body fluids.The reported information for a black piece of foreign material on the physicians gloves was analyzed using spectroscopy/ftir inspection.The fm particle was found to be spectrally similar to: propylene: diene which is a compound of a plastic or polymer.The definition of this compound is as follows: propylene diene monomer is a specific type of synthetic rubber.This may be consistent with the returned information that this may be a substance from the inserter the customer used.This compound is not used in the manufacturing of the comet device.Device analysis determined the condition of the returned device was consistent with the reported information.A piece of foreign material was confirmed.
 
Event Description
It was reported that a coating issue occurred.The target lesion was located in the left anterior descending artery (lad).A comet pressure guidewire was advanced and a normal ffr was performed in the lad and the device was removed.While advancing into the right coronary artery (rca), a black damaged part was noticed to be adhered to the physicians gloves.It was noted that the black material was likely the comet coating.It was additionally noted that it was possible that the interaction with an inserter contributed to the issue, but the exact cause was unknown.The black material did not enter the patient.The procedure was completed with another of the same device.No patient complications were reported in relation to this event and the patient condition was good following the procedure.
 
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Brand Name
COMET
Type of Device
TRANSDUCER, PRESSURE, CATHETER TIP
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9819476
MDR Text Key183118494
Report Number2134265-2020-02655
Device Sequence Number1
Product Code DXO
UDI-Device Identifier08714729904403
UDI-Public08714729904403
Combination Product (y/n)N
PMA/PMN Number
K151610
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 04/13/2020
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 Expiration Date07/20/2021
Device Model Number8900
Device Catalogue Number8900
Device Lot Number0024142561
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2020
Initial Date Manufacturer Received 02/19/2020
Initial Date FDA Received03/11/2020
Supplement Dates Manufacturer Received03/18/2020
Supplement Dates FDA Received04/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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