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

Model Number 2404-03

Device Problem Mechanical Problem (1384)

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

Event Date 01/26/2021

Event Type  malfunction  

Manufacturer Narrative

The returned product consisted of an ffr comet pressure wire disconnected from the comet ii occ cable.The occ cable/handle, tip, device shaft, and sensor port were visually and microscopically examined for damage or any irregularities.Inspection revealed the majority of the tip was stretched, and it was broken in two locations but was not able to be measured due to the tip being stretched.The stretched portion of the wire was also wrapped and stuck around the cable.The sensor looked to be too far distal which would give the indication of the sensor being detached from the fiber optic cable.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.Functional testing was conducted by placing the wire into the comet ii occ cable handle with no issues.Product analysis of the device did not confirm the reported event; however, analysis of the device found damage to the device that was not reported by the facility.

Event Description

Reportable based on analysis completed on 08mar2021.It was reported that connection failure occurred.During a procedure involving a comet ii pressure guidewire, the guidewire was removed from the connector to be used, but when it was attempted to be reconnected/attached again, it did not fit.The procedure was successfully completed with a different device without issue or patient injury.However, returned device analysis revealed device breaks.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11592150
• MDR Text Key: 243123433
• Report Number: 2134265-2021-03823
• 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: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/30/2021

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: 11/09/2022
• Device Model Number: 2404-03
• Device Catalogue Number: 2404-03
• Device Lot Number: 0026324515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 03/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2020
• 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