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

Model Number 2404-01

Device Problem Failure to Zero (1683)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2021

Event Type  malfunction  

Manufacturer Narrative

Device returned to manufacturer: the occ handle, tip, device shaft, proximal face, and sensor port were visually and microscopically examined for damage or any irregularities.Inspection of the device revealed that the shaft was separated at the seam weld which is 38cm from the tip.The ends of the separation were ovaled, indicating that the device had been kinked prior to separation.The sensor was then viewed through the sensor port and verified to be in the correct location.The wire was gently moved back and forth to see if the sensor would move.The sensor did not move which verifies that the fiber optics were connected to the sensor.The proximal end of the wire was inspected for any fiber optic cracks or damage and that is was polished correctly.The wire end showed no damage.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

Event Description

Reportable based on analysis completed 10 sep 2021.It was reported that the comet pressure guidewire was not recognized.There were no patient complications reported.However, returned device analysis revealed the device was fractured.

• Brand Name: COMET II
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12534332
• MDR Text Key: 273404071
• Report Number: 2134265-2021-12123
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 08714729960140
• UDI-Public: 08714729960140
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 09/27/2021

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: 04/13/2023
• Device Model Number: 2404-01
• Device Catalogue Number: 2404-01
• Device Lot Number: 0027129413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Initial Date Manufacturer Received: 09/10/2021
• Initial Date FDA Received: 09/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1