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

Model Number	8900
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2023.It was reported that the tip of the guidewire was stretched during use.A comet ii pressure guidewire was used for cardiac intervention.During the procedure, the tip of the guidewire was stretched, and the tip could not be shaped.After repeated attempts, it still could not reach the distal end of the blood vessel.Another pressure guidewire was used, and the procedure was completed.No patient complications were reported, and patient was stable post procedure.However, device analysis revealed that the tip was stretched for 7mm in length and detached at an unknown location.
Additional Manufacturer Narrative
Device evaluated by mfr.: the complaint device was received for product analysis.Returned product consisted of an ffr comet pressure wire with the occ cable.The occ cable, tip, and device shaft were visually and microscopically examined for damage or any irregularities.Inspection of the device revealed that the tip was stretched for 7mm in length and detached at an unknown location (due to the stretching of the tip, the detachment location cannot be measured).The ends of the detachment appeared to be smooth with material pushed up at an edge.The detached portion of the tip was not returned for analysis.The occ cable was then connected to the bench top testing equipment and the coefficient values were confirmed to be programmed.No other issues were identified during the product analysis.Product analysis confirmed the reported event, as the tip was stretched and detached.
Event or Problem Description
Reportable based on device analysis completed on 01sep2023.It was reported that the tip of the guidewire was stretched during use.A comet ii pressure guidewire was used for cardiac intervention.During the procedure, the tip of the guidewire was stretched, and the tip could not be shaped.After repeated attempts, it still could not reach the distal end of the blood vessel.Another pressure guidewire was used, and the procedure was completed.No patient complications were reported, and patient was stable post procedure.However, device analysis revealed that the tip was stretched for 7mm in length and detached at an unknown location.It was further reported that the tip of the device was stretched and there is no detached portion.Also, no fracture was noted.Device was completely removed from the patient body.
Additional Manufacturer Narrative
Device evaluated by mfr.: the complaint device was received for product analysis.Returned product consisted of an ffr comet pressure wire with the occ cable.The occ cable, tip, and device shaft were visually and microscopically examined for damage or any irregularities.Inspection of the device revealed that the tip was stretched for 7mm in length and detached at an unknown location (due to the stretching of the tip, the detachment location cannot be measured).The ends of the detachment appeared to be smooth with material pushed up at an edge.The detached portion of the tip was not returned for analysis.The occ cable was then connected to the bench top testing equipment and the coefficient values were confirmed to be programmed.No other issues were identified during the product analysis.Product analysis confirmed the reported event, as the tip was stretched and detached.

• 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 SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17824753
• Report Number: 2124215-2023-52743
• Device Sequence Number: 2440436
• 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
• Report Date (Section B): 10/10/2023

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: 12/02/2023
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0028488566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2023
• Supplement Date Received by Manufacturer: 10/07/2023
• Initial Report FDA Received Date: 09/27/2023
• Supplement Report FDA Received Date: 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2021
• 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: Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 79 KG