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

Model Number 8900

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of an ffr comet pressure wire connected to the occ cable.The tip, device shaft, sensor port and the coefficient values were examined for damage or any irregularities.The shaft showed 1 kink located 54cm from the tip.The tip showed kinks/bend damage.There was peeled coating at the 54cm location.The occ handle was connected to the ffr link for signal verification.The signal was present as designed.The occ handle cap was loosened to remove the wire.There was no issue with removing the wire.The sensor housing showed residue of body fluids.The wire was inserted into the pressure chamber test equipment and the pressure was increased to verify the sensor was indeed reacting to the pressure increases and decreases.The pressure sensor functioned as designed.The coefficient was confirmed to be in specification.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

Event Description

It was reported that a pressure signal was not recognized.During preparation of a ffr procedure and outside the patient body, a comet wire was connected to an ffr link, but the comet was not recognized by the polaris.Hub reconnection was performed, but the issue was not resolved.The procedure was completed with a non bsc device.No patient complications resulted from this event.However, device analysis revealed peeled coating.

• Brand Name: COMET
• 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 SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9376882
• MDR Text Key: 173938166
• Report Number: 2134265-2019-14269
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K151610
• 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: 11/26/2019

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: 8900
• Device Catalogue Number: 8900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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