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

Model Number 2404-02

Device Problem Failure to Advance (2524)

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

Event Date 01/31/2024

Event Type  malfunction  

Event Description

Reportable based on the device analysis completed on (b)(6) 2024.It was reported that the device could not cross lesion.The stenosed target lesion was located in the severely tortuous and calcified left anterior descending artery (lad).A comet ii was selected for use.During the procedure, it was noted that the device could not cross the lesion due to calcification.The procedure was completed with a different device.There were no patient complications reported post procedure.However, device analysis revealed that the tip was detached.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The shroud of the occ cable was connected to the bench top testing equipment.The rfid tag associated with this device is e004010841b12f80 for batch 29607201 and the coefficient values were confirmed to be programmed.The tip was detached and not returned for analysis.The shroud of the occ cable was connected to the ffr link to verify the signal strength.There were no issues in connecting to the ffr link.The signal was present and the signal strength and the zeroed led lights showed green, as designed.The green led lights indicated the wire was working properly.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 shroud of the occ cable was connected to the bench top testing equipment.The modulation was checked and was 6.9%.The wire was inserted into the pressure chamber.The pressure was increased to verify the sensor was indeed reacting to the pressure increases and decreases.The pressure sensor functioned as designed.

• 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: 19070318
• MDR Text Key: 339797456
• Report Number: 2124215-2024-19219
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Report Date: 04/09/2024

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: 2404-02
• Device Catalogue Number: 2404-02
• Device Lot Number: 0029607201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2022
• 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
• Patient Age: 85 YR
• Patient Sex: Male