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 05/12/2020

Event Type  malfunction  

Manufacturer Narrative

Device returned to manufacturer: the comet pressure guidewire was returned and analysis was completed.The tip, device shaft, sensor port and the coefficient values were examined for damage or any irregularities.The wire shaft showed a kink located 136cm from the tip.The tip showed bend damage and stretched coils.There was also peeled coating at this location of 136cm from tip.The occ cable was connected to the ffr link for signal verification.The signal was not present as designed.Device analysis was conducted by inspecting the proximal end of the wire for any damage to the fiber optic.No damage was noticed.The sensor was inspected by viewing the sensor port to verify that the sensor was in the correct location.This 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.The coefficient values were confirmed to be programmed per specification.The wire was removed from the occ handle with no issues.Inspection of the remainder of the device revealed no damage or irregularities.Device analysis determined the condition of the returned device was consistent with the reported information of signal/pressure issues.

Event Description

Reportable based on analysis completed 12 may 2020.It was reported that the comet pressure guidewire did not provide a pressure value.The procedure was completed with a different device.There were no patient complications reported.However, returned 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 CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10083500
• MDR Text Key: 191859715
• Report Number: 2134265-2020-06858
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 08714729904403
• UDI-Public: 08714729904403
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• 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: 0025115781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2020
• 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