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 03/03/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the returned product consisted of an ffr comet pressure wire connected to the occ cable.The tip, device shaft and sensor port were examined for damage or any irregularities.The wire shaft showed 2 kinks located 38cm and 139cm from the tip.Peeled coating on the shaft was noticed at the 139cm location.The tip showed bend damage.The occ cable was connected to the ffr link for signal verification.The signal was not present as designed.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.The coefficient values were confirmed to be programmed.The wire was removed from the occ handle with no issues.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.

Event Description

It was reported that signal issues with a pressure guidewire occurred.During preparation and while outside the patient, a comet device was connected to the console, but no pressure signal occurred.It was noted that the guidewire did not light up at the console, and the light on the console was red.Another comet was used to complete the procedure.No patient complications were reported in relation to tis event.However, the device was returned and 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 CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10676748
• MDR Text Key: 211244080
• Report Number: 2134265-2020-14095
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 08714729904397
• UDI-Public: 08714729904397
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K151610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/14/2020

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: 01/27/2022
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0025120425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2020
• 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