MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COMET II; TRANSDUCER, PRESSURE, CATHETER TIP

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.

• 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 Key: 13225123
• MDR Text Key: 283627816
• Report Number: 2134265-2022-00113
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 08714729960140
• UDI-Public: 08714729960140
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Date: 04/01/2023
• Device Model Number: 2404-01
• Device Catalogue Number: 2404-01
• Device Lot Number: 0027071892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2022
• Initial Date FDA Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1