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

Model Number 2404-01

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

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

Event Date 02/24/2023

Event Type  malfunction  

Event Description

It was reported that wire fracture occurred.The target lesion was located in a tortuous vessel.A comet ii pressure guidewire was advanced to take a diastolic hyperemia free ration (dfr) measurement.During the procedure, it was unable to get a measurement and the guidewire could not be moved.The physician scanned the guide catheter through fluoroscopy and found that the guidewire was broken inside the guide.Everything was then pulled out and another guidewire was used without any issues and the procedure was completed.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.The returned product consisted of the ffr comet pressure wire.The occ cable was not returned for analysis.The tip and device shaft were visually and microscopically examined for damage or any irregularities.Inspection of the device revealed that the distal shaft was separated/detached 26.5m proximal of the tip.The separated ends were ovaled, indicating that the device was kinked prior to separation and the tip was bent and kinked.The appearance of the confirmed damage was consistent to damage that can be caused from interaction with handling the device during preparation or the procedure and can be caused from interaction with another device or patient anatomy during the procedure.

Event Description

It was reported that wire fracture occurred.The target lesion was located in a tortuous vessel.A comet ii pressure guidewire was advanced to take a diastolic hyperemia free ration (dfr) measurement.During the procedure, it was unable to get a measurement and the guidewire could not be moved.The physician scanned the guide catheter through fluoroscopy and found that the guidewire was broken inside the guide.Everything was then pulled out and another guidewire was used without any issues and the procedure was completed.No patient complications were reported.

Manufacturer Narrative

H6 - device codes: corrected from a040101: fracture to a0501: detachment of device or device component.Device evaluated by mfr.: the returned product consisted of the ffr comet pressure wire.The occ cable was not returned for analysis.The tip and device shaft were visually and microscopically examined for damage or any irregularities.Inspection of the device revealed that the distal shaft was separated/detached 26.5m proximal of the tip.The separated ends were ovaled, indicating that the device was kinked prior to separation and the tip was bent and kinked.The appearance of the confirmed damage was consistent to damage that can be caused from interaction with handling the device during preparation or the procedure and can be caused from interaction with another device or patient anatomy during the procedure.

• Brand Name: COMET II
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16601531
• MDR Text Key: 312025475
• Report Number: 2124215-2023-13749
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 08714729960140
• UDI-Public: 08714729960140
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/20/2023

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: 2404-01
• Device Catalogue Number: 2404-01
• Device Lot Number: 0030627583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/23/2023
• Supplement Dates Manufacturer Received: 04/07/2023
• Supplement Dates FDA Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2022
• 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