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

Model Number	8655
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred.The 90% stenosed target lesion was located in the tortuous and non calcified right coronary artery.The opticross 6 imaging catheter was advanced for ultrasound examination of the target lesion.As the device was being removed with mild to moderate tension a pop was felt and it was noted that the tip of the device was separated from the shaft near the rapid exchange port.The tip remained on the wire.The wire and guide were carefully removed from the vessel with the detached tip not moving.A second 0.014 wire was used to wrap the distal portion of the wires together trapping the opticross tip on the first wire.Both wires were then removed with the tip secured to the first wire.There were no patient complications.Final angiography revealed timi 3 flow with 20% distal residual and a treated mid vessel dissection.
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection revealed a kink in the telescope assembly and a kink in the sheath assembly.Microscopic inspection revealed the guidewire exitport was torn along the monorail and the tip was detached.The distal housing could not be observed due to residues inside the imaging window.The device was sent for x-ray analysis of the distal housing condition which revealed no evidence of saline damage.Media inspection of pictures provided by the site showed the tip separation.
Event or Problem Description
It was reported that tip detachment occurred.The 90% stenosed target lesion was located in the tortuous and non calcified right coronary artery.The opticross 6 imaging catheter was advanced for ultrasound examination of the target lesion.As the device was being removed with mild to moderate tension a pop was felt and it was noted that the tip of the device was separated from the shaft near the rapid exchange port.The tip remained on the wire.The wire and guide were carefully removed from the vessel with the detached tip not moving.A second 0.014 wire was used to wrap the distal portion of the wires together trapping the opticross tip on the first wire.Both wires were then removed with the tip secured to the first wire.There were no patient complications.Final angiography revealed timi 3 flow with 20% distal residual and a treated mid vessel dissection.

• Brand Name: OPTICROSS 6
• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14274219
• Report Number: 2134265-2022-05070
• Device Sequence Number: 14913644
• Product Code: OBJ
• UDI-Device Identifier: 08714729904762
• UDI-Public: 08714729904762
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/21/2024
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0028722258
• 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: 04/14/2022
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male