MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS 18; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	44021
Medical Device Problem Codes	Entrapment of Device (1212); Poor Quality Image (1408); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter issue occurred.An opticross 18 peripheral imaging catheter was selected for use.The catheter was placed over a.018 guidewire and advanced successfully to the target lesion area.Imaging was turned on but only a dark image appeared.The catheter was flushed but that did not improve the image.After checking the electrical connection between the catheter and console, it was decided to remove the catheter.At this point it was observed that the guidewire was entangled around the catheter.The catheter was ultimately able to be removed without losing recanalization.A new device, same model was used to complete the procedure.There were no patient complications.
Event or Problem Description
It was reported that catheter issue occurred.An opticross 18 peripheral imaging catheter was selected for use.The catheter was placed over a.018 guidewire and advanced successfully to the target lesion area.Imaging was turned on but only a dark image appeared.The catheter was flushed but that did not improve the image.After checking the electrical connection between the catheter and console, it was decided to remove the catheter.At this point it was observed that the guidewire was entangled around the catheter.The catheter was ultimately able to be removed without losing recanalization.A new device, same model was used to complete the procedure.There were no patient complications.
Additional Manufacturer Narrative
Device eval by mfr: the device was returned, and technical analysis was completed.Visual inspection revealed the imaging window assembly was twisted.To inspect for damage in the imaging core at the proximal end of the catheter, the hub rotator retainer clip was removed.The rotator and imaging core assembly were pulled out from the hub.No damage was found within the telescope and sheath section of the device.Microscopic examination revealed that the guidewire exit port and tip were in good condition and the imaging window was twisted.The impedance test shows an electrical open proximal waveform between 150 and 160 cm from the distal housing.Functional testing was performed by inserting a test guidewire, and no indication of resistance in tracking the guidewire into the catheter was noted.

• Brand Name: OPTICROSS 18
• 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: 19949043
• Report Number: 2124215-2024-44564
• Device Sequence Number: 7602042
• Product Code: OBJ
• UDI-Device Identifier: 08714729904748
• UDI-Public: 08714729904748
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K160514
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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: 12/19/2025
• Device Model Number: 44021
• Device Catalogue Number: 44021
• Device Lot Number: 0033092361
• 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: 07/16/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown