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

Model Number 2404-04

Device Problem Failure to Advance (2524)

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

Event Date 12/14/2023

Event Type  malfunction  

Manufacturer Narrative

E1-initial reporter facility name: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.The occ cable, device body were visually and microscopically examined for damage or any irregularities.Inspection of the device revealed that the device was cut and only 38cm from the tip returned.The appearance of the cut area is consistent to the device being snipped from the customer site that occurred during handling of the device after the procedure.Functional testing of the device could not be completed due to the damage on the returned wire.The remainder of the wire was not returned.The occ cable was then connected to the bench top testing equipment.Product analysis could not confirm the reported difficulty of crossing the lesion due to the clinical circumstances could not be replicated.

Event Description

Reportable based on device analysis completed on 14feb2024.It was reported that the device could not cross the lesion.The 87% stenosed target lesion was located in the moderately tortuous and moderately calcified left circumflex artery.A comet ii was selected for use.During the procedure, it was noted that the device could not cross the lesion.The procedure was completed with another of same device.No complications were reported, and patient was stable post procedure.However, device analysis revealed that the device was cut and only 38cm from the tip was returned.

• Brand Name: COMET II
• Type of Device: ER, 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: 18836493
• MDR Text Key: 336979603
• Report Number: 2124215-2024-11406
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/05/2024

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 Expiration Date: 05/29/2024
• Device Model Number: 2404-04
• Device Catalogue Number: 2404-04
• Device Lot Number: 0029496441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2022
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 82 KG