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 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

The comet was returned for analysis: the tip, device shaft, sensor port and the coefficient values were examined for damage or any irregularities.The devices shaft showed three kinks located 38cm, 140cm from the tip and behind the occ handle collet.The tip showed a bend.There was peeled coating at the 140cm kink.The occ handle was connected to the ffr link for signal verification.The signal was not present as designed.The sensor port was inspected to verify that the sensor was connected to the fiber optic.It was noticed that the sensor was in the correct location in the sensor port.The wire was gently moved back and forth to see if the sensor would move.The sensor did not move which verifies that the fiber optics were connected to the sensor.The proximal end of the wire was inspected for any fiber optic cracks or damage and that is was polished correctly.The wire end showed no damage.The occ handle cap was loosened to remove the wire.There was no issue with removing the wire.The sensor port showed residue of body fluids.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

Event Description

Reportable based on analysis completed 14 jan 2020.It was reported that a recognition error had occurred with the comet pressure guidewire.The procedure was completed with another of the same device.There were no patient complications reported.Device analysis revealed some slight peeling of the device 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: 9672042
• MDR Text Key: 179236622
• Report Number: 2134265-2020-00937
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2020

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: 09/20/2021
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0024471742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 02/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2019
• 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