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

Model Number	2404-01
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred.The target lesion was located at the distal right coronary artery.A comet ii pressure guidewire was used.During procedure, there was no problem in delivering the comet ii guidewire down the distal right coronary artery.Physician then encountered resistance from the comet ii wire and would not exit the vessel.The comet ii wire was stuck at same position it was delivered.The physician continued to pull the wire to retrieve it; however, it could not be removed.The comet ii guidewire was pulled with more force and the distal part of the wire, the "radiopaque" portion, broke off in the vessel.The remaining part of the comet wire came out of the patient's body.The patient did not experience any adverse events and had been scheduled for a by-pass surgery because of triple vessel disease.Patient underwent successful coronary artery bypass grafting surgery, with no complications.The distal tip part of the comet wire was successfully removed from the right coronary artery during the by-pass procedure.
Additional Manufacturer Narrative
Updated e1: initial reporter details.Device evaluated by mfr: the complaint device was not received at the complaint investigation site (cis) for analysis.However, there was 4 photos in the complaint record (b)(4).All the photos were reviewed by the ah cis technician.One of the photos showed the packaging of the comet device and not the reported event.One showed the device coiled up in a biohazard bag but did not show the tip or any damage.Two other photos showed what appeared to be the distal end/tip of the wire inside the patient; however, there was not anything in the photo to confirm the reported event or any damage.Therefore, the photos were inconclusive.
Event or Problem Description
It was reported that tip detachment occurred.The target lesion was located in the right coronary artery.A comet ii guidewire was used.During procedure, there was no problem in delivering the comet ii wire down the distal right coronary artery.Physician then encountered resistance from the comet ii wire and would not exit the vessel.The comet ii wire was stuck at same position it was delivered.The physician continued to pull the wire to retrieve it, however, it would not be removed.The comet ii wire was pulled with more force and the distal part of the wire, the "radiopaque" portion, broke off in the vessel.The remaining part of the comet wire came out of the patient's body.The patient did not experience any adverse events and had been scheduled for by-pass surgery because of triple vessel disease.Patient underwent successful coronary artery bypass grafting surgery, with no complications.The distal part of the comet wire was successfully removed from the right coronary artery during by-pass procedure.It was further reported that the target lesion was located in the moderately calcified and mildly tortuous right coronary artery.Also, the catheter and guidewire were removed together was one unit.

• Brand Name: COMET II
• Common Device Name: 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19082761
• Report Number: 2124215-2024-21566
• Device Sequence Number: 12819375
• Product Code: DXO
• UDI-Device Identifier: 08714729960140
• UDI-Public: 08714729960140
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/04/2025
• Device Model Number: 2404-01
• Device Catalogue Number: 2404-01
• Device Lot Number: 0032355661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Female