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 02/04/2022

Event Type  malfunction  

Event Description

It was reported that the tip of the device had broken off.A procedure was being performed with a comet ii pressure guidewire.There were no device issues present upon opening the package.During the procedure, while the guidewire was inside the patient, the tip of the guidewire broke off due to excessive torqueing in the tortuous anatomy.The tip of the guidewire was successfully snared from the patient without further issue.There were no patient complications as a result of this event.

Manufacturer Narrative

H6 device code: fracture was corrected to be detachment of device or device component.Device evaluated by mfr.: the returned product consisted of the ffr comet pressure wire in two pieces with the occ cable.The rfid tag associated with this device was (b)(4).The occ cable, tip, device shaft, proximal face end, and sensor port were visually and microscopically examined for damage or any irregularities.Inspection of the device revealed that the distal shaft was detached/fractured at the end of the proximal end of the sensor housing at the first tri-cut on the distal end.There were numerous kinks throughout the body of the wire and the tip was bent and kinked.The shroud of the occ cable was connected to the bench top testing equipment, the coefficient values were confirmed to be programmed.The device was sent to mtac to perform sem imaging on the break in the wire to investigate the root cause.Mtac results found that the failure likely occurred due to reverse bending fatigue, with possible final ductile overload.Beam fracture surfaces appeared to show locations in the center of the fracture surface that appeared somewhat higher.This may suggest that while the physician was twisting/bending the tube (reverse bending fatigue) there was also a pulling force resulting in this surface characteristic.Tensile forces may have accelerated the fracture.Product analysis confirmed the reported event, as the comet ii wire was detached/fractured at end of the sensor housing where the tri-cuts start.

Event Description

It was reported that the tip of the device had broken off.A procedure was being performed with a comet ii pressure guidewire.There were no device issues present upon opening the package.During the procedure, while the guidewire was inside the patient, the tip of the guidewire broke off due to excessive torqueing in the tortuous anatomy.The tip of the guidewire was successfully snared from the patient without further issue.There were no patient complications as a result of this event.

• Brand Name: COMET II
• 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: 13931670
• MDR Text Key: 288058706
• Report Number: 2134265-2022-03447
• 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: 04/21/2022

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: 10/26/2023
• Device Model Number: 2404-01
• Device Catalogue Number: 2404-01
• Device Lot Number: 0028267436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2022
• Initial Date FDA Received: 03/28/2022
• Supplement Dates Manufacturer Received: 03/29/2022
• Supplement Dates FDA Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention