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

Model Number 8900

Device Problem Failure to Zero (1683)

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

Event Date 04/22/2022

Event Type  malfunction  

Manufacturer Narrative

Device returned to manufacturer: the occ cable, tip, device shaft, and sensor port were visually and microscopically examined for damage or any irregularities.Inspection revealed that there were numerous kinks/bends throughout the body of the wire and the tip was stretched.The distal end of the shaft was detached/fractured 29cm proximal of the tip.The detached ends were ovaled, indicating that the device was kinked prior to detachment.Device analysis was conducted by inspecting the sensor by viewing the sensor port to verify that the sensor was in the correct location.There were body fluids in the sensor housing and the sensor appeared to be inside the sensor housing 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.

Event Description

Reportable based on analysis completed on (b)(6) 2022.It was reported that the comet pressure guidewire was not recognized and zeroed.There were no patient complications reported.However, returned device analysis revealed a fractured device.

• 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: 14221833
• MDR Text Key: 290257940
• Report Number: 2134265-2022-04797
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2022

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: 05/27/2023
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0027392894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2022
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1