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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 2404-01
Device Problems Failure to Zero (1683); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/17/2021
Event Type  malfunction  
Event Description
Reportable based on analysis completed on 6 jan 2022.It was reported that the comet was not showing as connected when plugged into the ffr link.There were no patient complications reported.However, returned device analysis revealed the wire was fractured.
 
Manufacturer Narrative
Device returned to manufacturer: the occ cable handle, tip, device shaft, proximal face end, and sensor port were visually and microscopically examined for damage or any irregularities.Inspection of the device revealed that the wire was fractured at the seam weld, 38cm proximal of the tip.The fractured ends of the wire were ovaled, indicating that the seam weld was kinked prior to the fracture.Device analysis was conducted by inspecting the sensor by viewing the sensor port to verify that the sensor was in the correct location.This sensor looked to be completely inside the sensor housing detached from the fiber optic cable with body fluids in the sensor housing.The wire was gently shaken to see if the sensor would move within the sensor housing and the sensor did move which verifies the sensor was detached from the fiber optic.The proximal end face of the wire was inspected for any fiber optic cracks or damage and that it was polished correctly.The wire end showed the proximal end face was cracked.The handle was dismantled to see if there was any damage or irregularities.When the handle was dismantled, it was found that the wire appears to have punctured with a hole in the polymer disk.The polymer disk is what the wire pushes against within the occ handle and helps protect the fiber face to ensure the two fibers stay in close contact so that light passes through without refracting.So, with the disk punctured, this can result in a reduction in signal strength.Significant or continual wire manipulation would most likely be needed to cause damage to the proximal end face and the polymer disk.Also, when the proximal end face is damaged, when it is seated in the handle the signal cant reach the sensor, causing no signal.
 
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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
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13225123
MDR Text Key283627816
Report Number2134265-2022-00113
Device Sequence Number1
Product Code DXO
UDI-Device Identifier08714729960140
UDI-Public08714729960140
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 01/11/2022
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 Date04/01/2023
Device Model Number2404-01
Device Catalogue Number2404-01
Device Lot Number0027071892
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/06/2022
Initial Date FDA Received01/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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