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

Model Number	H7493932800350
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter issue occurred.The target lesion was located in the right iliac vein.An opticross 35 imaging catheter was chosen for ultrasound examination of the target lesion.During the procedure, while advancing the catheter over the guidewire, the back end of the wire punctured through the sidewall of the catheter.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection revealed sheath was damaged.Microscopic inspection revealed that the sheath was perforated and has a hole.The reported issue of guidewire stuck was confirmed.The hole was observed under magnification crossing the guidewire lumen into the surface of the sheath, and it was noticed that the surface of the material shows evidence of tearing forces related to a puncture cause by tension.Based on the direction of the tear, the force was applied from the inside of the lumen.The reported issue was confirmed.
Event or Problem Description
It was reported that a catheter issue occurred.The stenosed target lesion was located in the right iliac vein.An opticross 35 imaging catheter was chosen for ultrasound examination of the target lesion.During the procedure, while advancing the catheter over the wire, the back end of the guidewire punctured through the sidewall of the catheter.The procedure was completed with another of the same device.There were no patient complications reported.

• 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: 19766513
• Report Number: 2124215-2024-40806
• Device Sequence Number: 12917822
• Product Code: OBJ
• UDI-Device Identifier: 08714729984542
• UDI-Public: 08714729984542
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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
• Report Date (Section B): 09/12/2024

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: 03/13/2026
• Device Model Number: H7493932800350
• Device Catalogue Number: H7493932800350
• Device Lot Number: 0034106983
• 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: 06/18/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Race: White