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

Model Number	8655
Medical Device Problem Codes	Entrapment of Device (1212); Poor Quality Image (1408); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occurred.The 70% stenosed target lesion was located in the mildly tortuous and mildly calcified circumflex artery.After a 190 non-boston scientific guidewire was place, the opticross 6 imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.Once the catheter was close to the artery, imaging was turned on.The physician felt some resistance with the ivus wire that had a knuckle on it and came back a bit.While the catheter was in use, there were issues with imaging.The physician removed the catheter and noticed there was wire wrap up.A new ivus catheter was used to complete the procedure.There were no patient complications.
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection revealed the telescope assembly was kinked.No imaging core windup was found within the telescope section and the sheath section of the device.The sleeve was observed detached from the telescope and the tip was stuck on the floppy end of the guidewire.Microscopic inspection revealed the guidewire exit port was deformed, but the tip was in good condition.Impedance testing showed an electrical open at the proximal wave form.The complaint device was sent for x-ray analysis to further characterize the electrical failure.Based on the x-ray analysis the electrical issue was the result of a broken coax cable approximately 130-140cm from distal housing.
Event or Problem Description
It was reported that device entrapment occurred.The 70% stenosed target lesion was located in the mildly tortuous and mildly calcified circumflex artery.After a 190 non-boston scientific guidewire was place, the opticross 6 imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.Once the catheter was close to the artery, imaging was turned on.The physician felt some resistance with the ivus wire that had a knuckle on it and came back a bit.While the catheter was in use, there were issues with imaging.The physician removed the catheter and noticed there was wire wrap up.A new ivus catheter was used to complete the procedure.There were no patient complications.

• Brand Name: OPTICROSS 6
• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16710288
• Report Number: 2124215-2023-16704
• Device Sequence Number: 7362244
• Product Code: OBJ
• UDI-Device Identifier: 08714729904762
• UDI-Public: 08714729904762
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161125
• 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): 06/05/2023

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: 11/15/2024
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0030551002
• 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: 03/23/2023
• Supplement Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 190 RUNTHROUGH GUIDEWIRE; 190 RUNTHROUGH GUIDEWIRE
• Patient Sex: Unknown