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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 Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/07/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that a guidewire break occurred.During preparation, outside the patient, and while removing a comet pressure guidewire from the free spin handle, it was noticed that the wire had broken.The procedure was completed with another of the same device.No patient complications were reported in relation to this event.
 
Manufacturer Narrative
B5: corrected event description e1: state: yamaguchi perfecture device evaluated by mfr: the product was returned to boston scientific for analysis.Returned product consisted of an occ handle only, the wire was not returned.Since the guidewire was not returned, this analysis was conducted on the occ handle only.The collet and cap were not returned on the returned the occ handle.A.014 test comet pressure wire was used to test the functionality of the occ handle.A collet and cap from a test occ handle were used on the returned occ handle.The wire was inserted into the occ handle and connected to the ffr link.The wire showed a signal with green lights.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.With the wire inserted into the test pressure chamber, 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 revealed no damage or irregularities.The analysis with the test components did not show any abnormalities when testing the device.Since the original components of the device were not returned the complaint was not confirmed for detachment of the wire and occ handle malfunctions.
 
Event Description
It was reported that a guidewire break occurred.During preparation, outside the patient, and while removing a comet pressure guidewire from the free spin handle, it was noticed that the wire had broken.The procedure was completed with another of the same device.No patient complications were reported in relation to this event.It was further reported that while disconnecting the wire from the occ handle, the cap part of the occ handle became detached.The handle was removed together with the wire.After disconnecting the wire from the handle, the wire was not able to reconnect to the handle.No damage was noted in the wire.No patient complications were reported in relation to this event.
 
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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 Key10013265
MDR Text Key189747709
Report Number2134265-2020-05822
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 06/11/2020
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 Date01/08/2022
Device Model Number8900
Device Catalogue Number8900
Device Lot Number0025016401
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/24/2020
Initial Date Manufacturer Received 04/07/2020
Initial Date FDA Received04/30/2020
Supplement Dates Manufacturer Received05/19/2020
Supplement Dates FDA Received06/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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