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

Model Number 2404-03

Device Problem Failure to Zero (1683)

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

Event Date 05/26/2023

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(6) 2023.It was reported that device failed to zero occurred.A comet ii pressure guidewire was selected for the procedure.During connection, the wire had a recognition failure.The procedure was completed with another of the same device.No patient injury was reported.However, device analysis revealed that the distal shaft/body was detached/separated.

Manufacturer Narrative

The device was returned for analysis.The occ cable, 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 there were numerous kinks throughout the body of the wire, the tip was bent, and the distal shaft/body was detached/separated approximately 32.6ccm proximal of the tip.The separated ends of the wire were bent and jagged, indicating the device was kinked prior to detachment/separation.The shroud of the occ cable was connected to the bench top testing equipment.The rfid tag associated with this device and the coefficient values were confirmed to be programmed.The sensor appeared to be inside the sensor housing detached from the fiber optic cable with body fluids.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.

Event Description

Reportable based on device analysis completed on 26jun2023.It was reported that device failed to zero occurred.A comet ii pressure guidewire was selected for the procedure.During connection, the wire had a recognition failure.The procedure was completed with another of the same device.No patient injury was reported.However, device analysis revealed that the distal shaft/body was detached/separated.It was further reported that the device was removed intact from the patient's body, and that the separation occurred after the procedure.

Manufacturer Narrative

The device was returned for analysis.The occ cable, 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 there were numerous kinks throughout the body of the wire, the tip was bent, and the distal shaft/body was detached/separated approximately 32.6ccm proximal of the tip.The separated ends of the wire were bent and jagged, indicating the device was kinked prior to detachment/separation.The shroud of the occ cable was connected to the bench top testing equipment.The rfid tag associated with this device and the coefficient values were confirmed to be programmed.The sensor appeared to be inside the sensor housing detached from the fiber optic cable with body fluids.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.

• Brand Name: COMET II
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17378006
• MDR Text Key: 319610853
• Report Number: 2124215-2023-38833
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/02/2023

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 Model Number: 2404-03
• Device Catalogue Number: 2404-03
• Device Lot Number: 0030436105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2023
• Initial Date FDA Received: 07/24/2023
• Supplement Dates Manufacturer Received: 07/26/2023
• Supplement Dates FDA Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1