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

Model Number	8655
Medical Device Problem Codes	Poor Quality Image (1408); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device detachment occurred.The 70% stenosed target lesion was located in a mildly calcified and mildly tortuous left anterior descending artery.An opticross imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure the image went dark and when the catheter was removed it was found broken at the lapjoint.The drive shaft appeared intact.The procedure was completed with a different device.There were no patient complications.
Event or Problem Description
It was reported that device detachment occurred.The 70% stenosed target lesion was located in a mildly calcified and mildly tortuous left anterior descending artery.An opticross imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure the image went dark and when the catheter was removed it was found broken at the lapjoint.The drive shaft appeared intact.The procedure was completed with a different device.There were no patient complications.
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection revealed the imaging window was detached near the lapjoint section.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.It was observed that the catheter flushed normally when the imaging core was fully retracted and fully advanced.Impedance testing showed a good unit wave form.Image test could not be performed due to the condition in which the device returned.

• Brand Name: OPTICROSS
• 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: 14854314
• Report Number: 2134265-2022-07507
• Device Sequence Number: 5219537
• Product Code: OBJ
• UDI-Device Identifier: 08714729847878
• UDI-Public: 08714729847878
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Non-Healthcare Professional
• 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: 02/04/2023
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0028781514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2022
• 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
• Patient Sex: Unknown