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

Model Number	2404-01
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred.The target lesion was located in the circumflex coronary artery.A comet ii pressure guidewire was advanced to the lesion to take a diastolic hyperemia-free ration (dfr) measurement.The dfr was negative, so the physician opted to use intravascular ultrasound (ivus) for further information collection.During procedure, while loading the opticross 6 hd on the wire, there was resistance, so the wire was wiped clean and then the opticross tracked smoothly down the wire.A single intravascular ultrasound (ivus) run was successfully performed but, when the physician attempted to remove the opticross there was a lot of resistance.The physician then removed the comet wire and opticross catheter together as a system, however the distal tip of the wire had sheared off and was retained in the left main artery.An attempt was made to snare the tip of the wire, but this caused the detached part to migrate into the ramus artery where it was then stented into place.No patient complications were reported.
Event or Problem Description
It was reported that tip detachment occurred.A comet ii pressure guidewire was advanced to the lesion to take a diastolic hyperemia-free ration (dfr) measurement.The dfr was negative, however the physician opted to use intravascular ultrasound (ivus) for further information collection.During procedure, while loading the opticross 6 hd on the wire, there was resistance, so the wire was wiped clean and then the opticross tracked smoothly down the wire.A single intravascular ultrasound (ivus) run was successfully performed using a sled, however when the physician attempted to remove the opticross there was a lot of resistance.Physician then removed the comet wire and opticross together as a system, however the distal tip of the wire had sheared off and was retained in the left main/guide catheter.An attempt was made to snare the tip of the wire, and this caused it to migrate into the ramus artery where it was then stented into place.No adverse events were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.A visual inspection identified that there was blood on the outside of the device.Only portion of the wire was returned.The shaft was received detached in two pieces.Portion of the distal end (approx.4.4cm) which includes the portion of the distal shaft, the sensor housing, sensor, and tip were not returned for analysis.Only approx.180.6cm of the shaft was returned.The first separation of the body of the wire was detached 174.6cm from the proximal end, with the second separation approx.180.6cm from the proximal end.The separated ends were ovaled, indicating the shaft of the body was kinked prior to separation.The distal end of the wire (second separation) was bent.The appearance of the separated ends is consistent to damage that can occur due to force or torque of the device during use from interaction with another device or patient anatomy during the procedure.The photos attached to the complaint record were reviewed.There were two photos of wire in the patients anatomy that appear to show it separated.The other photo shows the wire outside the body on a white piece of paper in two sections and the received device matches the appearance of this photo.No other issues were identified during the product analysis.

• 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: 19262295
• Report Number: 2124215-2024-27336
• Device Sequence Number: 6492796
• Product Code: DXO
• UDI-Device Identifier: 08714729960140
• UDI-Public: 08714729960140
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/18/2024

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: 09/28/2025
• Device Model Number: 2404-01
• Device Catalogue Number: 2404-01
• Device Lot Number: 0032530409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2023
• 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: Other; Required Intervention
• Patient Sex: Unknown