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	11/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidewire punctured the catheter.The 95% stenosed target lesion was located in the non-tortuous and very tightly calcified subclavian artery.An opticross 35 and amplatz guidewire were selected for arterial intervention.However, while advancing the catheter over the wire, the back end of the wire exited the side of the shaft of the catheter, basically poking a hole through the wall.The device was removed intact, and the procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
D2b - pro code (product code): obj, itx.
Event or Problem Description
It was reported that the guidewire punctured the catheter.The 95% stenosed target lesion was located in the non-tortuous and very tightly calcified subclavian artery.An opticross 35 and amplatz guidewire were selected for arterial intervention.However, while advancing the catheter over the wire, the back end of the wire exited the side of the shaft of the catheter, basically poking a hole through the wall.The device was removed intact, and the procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
D2b - pro code (product code): obj, itx.Device evaluated by mfr: the complaint device was received for product analysis.Visual inspection was performed, and it was revealed that no issues were found, and the device appears to be in good conditions.No damages or failures were observed on the ccp (catheter code pcba) board assembly.During microscopic inspection, the guidewire exit port and tip were in good condition.An impedance test was performed with the above referenced calibrated equipment.Impedance testing shows an electrical open distal wave form.A test guidewire was inserted and no indication of resistance in tracking the guidewire into the catheter was noted.The mdu and ilab system were used to perform a functional inspection on the device.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.No other issues were identified during the product analysis.Based on the evidence, the damaged/defective can be confirmed, since the open distal found during the impedance test could have contributed to image lost.The device interaction with another device cannot be confirmed, since this code was not found during product analysis and only the device was returned.

• 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; 302 parkway, global park; la aurora - heredia 55112 ; CS 55112
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 6128757234
• MDR Report Key: 20953983
• Report Number: 2124215-2024-75717
• Device Sequence Number: 15372431
• Product Code: OBJ
• UDI-Device Identifier: 08714729984542
• UDI-Public: 08714729984542
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/06/2025

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: H7493932800350
• Device Catalogue Number: H7493932800350
• 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: 11/21/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 12/17/2024
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 62 YR
• Patient Sex: Male
• Patient Race: Black Or African American