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

Model Number 2404-02

Device Problem Material Deformation (2976)

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

Event Date 01/03/2023

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(6)2023.It was reported that kinked occurred.The target lesion was located in the severely tortuous and severely calcified proximal right coronary artery.A comet ii pressure guidewire was selected for use.During the procedure, while crossing the lesion, the device was kinked.The procedure was completed with another of the same device.No patient complications were reported, and patient was stable.However, device analysis revealed that the tip of the device was partially detached.

Manufacturer Narrative

Device eval by manufacturer: the complaint device was received for product analysis.The occ handle, tip and device shaft were visually 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, stretched, and partially separated/detached.The appearance of the confirmed kinks and tip damage is consistent to damage that can be caused from interaction with another device or patient anatomy during preparation/procedure.No other issues were identified during the product analysis.

• 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: 17565821
• MDR Text Key: 321366639
• Report Number: 2124215-2023-43667
• 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: 08/17/2023

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 Expiration Date: 10/18/2023
• Device Model Number: 2404-02
• Device Catalogue Number: 2404-02
• Device Lot Number: 0028225311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2021
• 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 Sex: Female