MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS 35; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	H7493932800350
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter issue occurred.An opticross 35 ivus vascular imaging catheter was selected to treat a patient with peripheral artery disease (pad) / peripheral vascular disease (pvd).During the preparation, the guidewire punctured a hole through the catheter.The procedure was completed with another device.No patient complications were provided.
Event or Problem Description
It was reported that a catheter issue occurred.An opticross 35 ivus vascular imaging catheter was selected to treat a patient with peripheral artery disease (pad) / peripheral vascular disease (pvd).During the preparation, the guidewire punctured a hole through the catheter.The procedure was completed with another device.No patient complications were provided.It was further reported that the guidewire pierced through the catheter distal to the transducer.The issue occurred prior to the procedure during preparation.
Event or Problem Description
It was reported that a catheter issue occurred.An opticross 35 ivus vascular imaging catheter was selected to treat a patient with peripheral artery disease (pad) / peripheral vascular disease (pvd).During the preparation, the guidewire punctured a hole through the catheter.The procedure was completed with another device.No patient complications were provided.It was further reported that the guidewire pierced through the catheter distal to the transducer.The issue occurred prior to the procedure during preparation.
Additional Manufacturer Narrative
Device evaluation by manufacturer: visual inspection showed that no issues were found, the device appears to be in good condition.No damages or failures were observed on the ccp (catheter code pcba) board assembly.The guidewire exit port, and the tip were in good condition.The impedance test shows an electrical open distal waveform between 0-10 cm from the distal housing.A test guidewire was inserted and no indication of resistance in tracking the guidewire into the catheter was noted.The catheter was properly recognized by the imaging system when plugged into the mdu and no connection issues or errors were detected during its testing.

• Brand Name: OPTICROSS 35
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20345671
• Report Number: 2124215-2024-61245
• Device Sequence Number: 20833073
• Product Code: OBJ
• UDI-Device Identifier: 08714729984542
• UDI-Public: 08714729984542
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200733
• 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,Followup
• Report Date (Section B): 12/13/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/05/2025
• Device Model Number: H7493932800350
• Device Catalogue Number: H7493932800350
• Device Lot Number: 0032892142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 10/09/2024; 11/26/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 11/05/2024; 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown