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

Model Number	8900
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred.The comet pressure guidewire was used for ffr detection on the left circumflex artery (lcx) and the left anterior descending (lad) artery.The ffr result of the lcx was 0.82, and the ffr result of the lad was 0.71.The lad was treated first.Percutaneous coronary intervention was performed with the comet pressure guidewire which was used as the working wire for the lad.During advancement of the wire, resistance was encountered.A balloon catheter and cutting balloons were used to expand the lesions.After ptca pretreatment, a 3.0 x 36mm stent was implanted, and the comet pressure guidewire was connected to the handle for a final post-lad ffr test.The comet pressure guidewire was withdrawn to the middle segment of the lad stent, and resistance was felt during withdrawal.The physician continued to pull back, and the angiography showed that the end of the come pressure guidewire fractured in the stent.The broken end of the comet pressure guidewire was removed by extending the catheter together with the balloon.The procedure time was 90 minutes.There were no patient complications, and the patient was stable.
Event or Problem Description
It was reported that tip detachment occurred.The comet pressure guidewire was used for ffr detection on the left circumflex artery (lcx) and the left anterior descending (lad) artery.The ffr result of the lcx was 0.82, and the ffr result of the lad was 0.71.The lad was treated first.Percutaneous coronary intervention was performed with the comet pressure guidewire which was used as the working wire for the lad.During advancement of the wire, resistance was encountered.A balloon catheter and cutting balloons were used to expand the lesions.After ptca pretreatment, a 3.0 x 36mm stent was implanted, and the comet pressure guidewire was connected to the handle for a final post-lad ffr test.The comet pressure guidewire was withdrawn to the middle segment of the lad stent, and resistance was felt during withdrawal.The physician continued to pull back, and the angiography showed that the end of the comet pressure guidewire fractured in the stent.The broken end of the comet pressure guidewire was removed by extending the catheter together with the balloon.The procedure time was 90 minutes.There were no patient complications, and the patient was stable.
Additional Manufacturer Narrative
Corrected field h6: impact code f23 is being used to capture the reportable issue of unexpected medical intervention.
Event or Problem Description
It was reported that tip detachment occurred.The comet pressure guidewire was used for ffr detection on the left circumflex artery (lcx) and the left anterior descending (lad) artery.The ffr result of the lcx was 0.82, and the ffr result of the lad was 0.71.The lad was treated first.Percutaneous coronary intervention was performed with the comet pressure guidewire which was used as the working wire for the lad.During advancement of the wire, resistance was encountered.A balloon catheter and cutting balloons were used to expand the lesions.After ptca pretreatment, a 3.0 x 36mm stent was implanted, and the comet pressure guidewire was connected to the handle for a final post-lad ffr test.The comet pressure guidewire was withdrawn to the middle segment of the lad stent, and resistance was felt during withdrawal.The physician continued to pull back, and the angiography showed that the end of the come pressure guidewire fractured in the stent.The broken end of the comet pressure guidewire was removed by extending the catheter together with the balloon.The procedure time was 90 minutes.There were no patient complications, and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was visually and microscopically examined for damage or any irregularities.Visual inspection revealed numerous kinks throughout the body of the wire and the tip was detached and not returned for analysis.The detached end of the tip was stretched and twisted.There was forced applied to the tip that caused it to be stretched to the point of detachment.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The complaint of detachment of the device was confirmed.

• Brand Name: COMET
• 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: 18359972
• Report Number: 2124215-2023-72101
• Device Sequence Number: 8014715
• Product Code: DXO
• UDI-Device Identifier: 08714729904397
• UDI-Public: 08714729904397
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/08/2024

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: 12/12/2023
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0028542956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/08/2023; 01/29/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 12/20/2023; 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2021
• 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
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 45 KG