COMET 8900

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-02-26 for COMET 8900 manufactured by Boston Scientific Corporation.

Event Text Entries

[181189371] (b)(6). Device returned to manufacturer. The comet was returned and analysis was completed. The tip, device shaft, sensor port and the coefficient values were examined for damage or any irregularities. The devices shaft showed two kinks located 176. 5cm and at the occ handle. There was some peeled coating at the 176. 5 location. The occ handle was connected to the ffr link to verify the signal strength. The signal was present as designed. The sensor port showed no residue of body fluids. 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 was confirmed to be within specification 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. Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
Patient Sequence No: 1, Text Type: N, H10


[181189372] Reportable based on analysis completed 4 feb 2020. It was reported that recognition issue occurred. It was reported that the comet pressure guidewire was not recognized. The procedure was completed with another of the same device. There were no patient complications reported. However, returned device analysis revealed peeled coating.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-02102
MDR Report Key9758208
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-02-26
Date of Report2020-02-26
Date of Event2019-12-12
Date Mfgr Received2020-02-04
Device Manufacturer Date2019-04-16
Date Added to Maude2020-02-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJAY JOHNSON
Manufacturer StreetTWO SCIMED PLACE
Manufacturer CityMAPLE GROVE MN 55311
Manufacturer CountryUS
Manufacturer Postal55311
Manufacturer Phone7634942574
Manufacturer G1BOSTON SCIENTIFIC CORPORATION
Manufacturer StreetTWO SCIMED PLACE
Manufacturer CityMAPLE GROVE MN 55311
Manufacturer CountryUS
Manufacturer Postal Code55311
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOMET
Generic NameTRANSDUCER, PRESSURE, CATHETER TIP
Product CodeDXO
Date Received2020-02-26
Returned To Mfg2020-01-22
Model Number8900
Catalog Number8900
Lot Number0023653441
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer AddressTWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-26

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