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	06/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code: obj, itx.
Event or Problem Description
It was reported that device perforation occurred.The patient presented for a lower extremity venous intervention.When the opticross35 imaging catheter was being loaded onto the guidewire, the wire punctured through the lumen of the catheter and exited close to the distal end of the catheter and not through the wire lumen hub on the proximal end.The procedure was completed with another of the same device.There were no patient complications.
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection revealed a kink in the sheath assembly.During microscopic inspection noted pitting and degradation of the transducer housing consistent with saline damage which occurs post-use of the device and is not related to the original device failure.A perforation was observed in the sheath near the kinked section.
Event or Problem Description
It was reported that device perforation occurred.The patient presented for a lower extremity venous intervention.When the opticross35 imaging catheter was being loaded onto the guidewire, the wire punctured through the lumen of the catheter and exited close to the distal end of the catheter and not through the wire lumen hub on the proximal end.The procedure was completed with another of the same device.There were no patient complications.

• Brand Name: OPTICROSS 35
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14988671
• Report Number: 2134265-2022-07824
• Device Sequence Number: 19251099
• Product Code: OBJ
• UDI-Device Identifier: 08714729984542
• UDI-Public: 08714729984542
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/16/2022

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: 10/11/2022
• Device Model Number: H7493932800350
• Device Catalogue Number: H7493932800350
• Device Lot Number: 0028876115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2021
• 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
• Patient Sex: Male