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

Model Number	8655
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter twist and fracture occurred.The opticross imaging catheter was advanced for ultrasound examination of the target lesion.No friction was noted when loading the catheter but after imaging was started, resistance occurred.Upon pullback the catheter became wrapped around the 0.014 guidewire and imaging stopped since the catheter was no longer able to rotate.The catheter and wire had to be removed together as a unit and the procedure was completed with another of the same device.The catheter was noted to have multiple kinks at the distal exchange area and proximal portion at the cone and multiple fractures.There were no patient complications.
Event or Problem Description
It was reported that catheter twist and fracture occurred.The opticross imaging catheter was advanced for ultrasound examination of the target lesion.No friction was noted when loading the catheter but after imaging was started, resistance occurred.Upon pullback the catheter became wrapped around the 0.014 guidewire and imaging stopped since the catheter was no longer able to rotate.The catheter and wire had to be removed together as a unit and the procedure was completed with another of the same device.The catheter was noted to have multiple kinks at the distal exchange area and proximal portion at the cone and multiple fractures.There were no patient complications.
Additional Manufacturer Narrative
Device eval by mfr: the device was returned for analysis.Visual inspection revealed the sheath and imaging window were kinked and the imaging window was twisted.Microscopic inspection revealed the guidewire exit port was deformed but the tip was in good condition.Functional test with the guidewire 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; 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: 17071953
• Report Number: 2124215-2023-28739
• Device Sequence Number: 20357173
• Product Code: OBJ
• UDI-Device Identifier: 08714729847878
• UDI-Public: 08714729847878
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2023

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: 02/15/2024
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0031060083
• 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: 05/19/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2023
• 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