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

Model Number 2404-02

Device Problem Calibration Problem (2890)

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

Event Date 09/26/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of the proximal and middle portion of the comet pressure wire with the cable.The cable, tip, comet pressure wire shaft, and sensor port were visually and microscopically examined for damage or any irregularities.Inspection of the device revealed that the shaft was detached with numerous kinks throughout the body of the wire.The shaft was detached 122cm distal of the proximal end.The appearance of the separated end indicate that the shaft was kinked prior to detachment.The distal portion of the shaft, including the sensor and tip were not returned for analysis.The proximal end of the wire was inspected for any fiber optic cracks or damage and that was polished correctly.The wire end was damaged/cracked.The handle was dismantled to see if there was any damage or irregularities.When the handle was dismantled, it was found that the wire appeared to have punctured the polymer disc.The polymer disc is what the wire pushes against within the handle and helps protect the fiber face to ensure the two fibers stay in close contact so that light passes through without refracting.With the disc punctured, this can result in a reduction in signal strength.Significant or continual wire manipulation e.G., reinserting the wire into the handle many times or reinserting with high force, would most likely be needed to cause damage to the proximal end face and the polymer disc.When the proximal end face is damaged, the signal cannot reach the sensor, causing no signal.Product analysis did not confirm the reported event, as the wire was returned detached/separated and was not able to be tested.

Event Description

Reportable based on returned device analysis completed on (b)(6) 2022.It was reported that failure to equalize occurred.A comet pressure guidewire was prepared for use; however, the comet pressure guidewire failed to equalize.The procedure was completed with a new comet pressure guidewire.No patient complications were reported.However, returned device analysis revealed a separation of the comet pressure guidewire.

• Brand Name: COMET II
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15880066
• MDR Text Key: 304814539
• Report Number: 2124215-2022-49305
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2023
• Device Model Number: 2404-02
• Device Catalogue Number: 2404-02
• Device Lot Number: 0028509058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2021
• 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: Male