MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS? 6 HD; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	H74939354080
Medical Device Problem Codes	Entrapment of Device (1212); Device-Device Incompatibility (2919); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4: premarket/510(k) # k173820, k213593.
Event or Problem Description
It was reported that a catheter issue occurred.Thet 95% stenosed target lesion was located in the severely tortuous and moderately calcified vessel.An opticross 6 hd imaging catheter was selected for ultrasound examination of the lesion.A patient undergoing treatment for coronary artery disease (cad) was being evaluated using an intravascular ultrasound (ivus) catheter, which was prepared in accordance with the device instructions for use (dfu) and advanced into the target vessel.During the procedure, the catheter could not cross an implanted unknown stent proximal to the lesion due to significant resistance.When the physician attempted to remove the catheter, the non-boston scientific (bsc) guidewire came out with it.Upon inspection, the non-bsc wire was found to be bonded to the outside of the catheter and could not be separated.The catheter and non-bsc wire were removed together as one unit.The procedure was completed using an alternate device, and there were no patient complications.
Event or Problem Description
It was reported that a catheter issue occurred.Thet 95% stenosed target lesion was located in the severely tortuous and moderately calcified vessel.An opticross 6 hd imaging catheter was selected for ultrasound examination of the lesion.A patient undergoing treatment for coronary artery disease (cad) was being evaluated using an intravascular ultrasound (ivus) catheter, which was prepared in accordance with the device instructions for use (dfu) and advanced into the target vessel.During the procedure, the catheter could not cross an implanted unknown stent proximal to the lesion due to significant resistance.When the physician attempted to remove the catheter, the non-boston scientific (bsc) guidewire came out with it.Upon inspection, the non-bsc wire was found to be bonded to the outside of the catheter and could not be separated.The catheter and non-bsc wire were removed together as one unit.The procedure was completed using an alternate device, and there were no patient complications.
Additional Manufacturer Narrative
G4: premarket / 510(k) # k173820, k213593.The device was returned for analysis.Visual and microscopic inspections revealed that the tip was stuck with the guidewire, and the guidewire exit port was lifted and stuck.Device analysis confirmed the allegation of reported event of catheter resistance/friction.The returned device presented no damage which confirm the reported event of guidewire entanglement.

• Brand Name: OPTICROSS? 6 HD
• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21891363
• Report Number: 2124215-2025-23910
• Device Sequence Number: 20869671
• Product Code: OBJ
• UDI-Device Identifier: 08714729960775
• UDI-Public: (01)08714729960775(17)270122(10)35686232
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K173820
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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 Model Number: H74939354080
• Device Catalogue Number: H74939354080
• Device Lot Number: 0035686232
• 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: 04/01/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2025
• 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
• Patient Sex: Unknown