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

Model Number 44021

Device Problems Entrapment of Device (1212); Poor Quality Image (1408); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2023

Event Type  malfunction  

Event Description

It was reported that catheter issue occurred.The patient presented with a peripheral artery disease on the lower limb.Vascular access was obtained utilizing the arm and ipsilateral approach using the common femoral artery.The totally occluded target lesion was located in the moderately tortuous and mildly calcified iliac artery.The opticross 18 imaging catheter was advanced for ultrasound examination of the target lesion through the ipsilateral side.During the procedure, the catheter was stuck near the lesion while imaging.Vibration was felt at the hand base side of the catheter while the motor drive unit was moving and then the image was lost.The device was removed, and the tip was wavy, and kinks were noted.The procedure was completed with another of the same device.There was no patient injury reported.

Manufacturer Narrative

The device was returned for analysis.Visual inspection revealed the imaging window was kink and the catheter was twisted beginning 8.6cm and 13.3cm from the lap joint section.Inspection for imaging core windup revealed a broken drive shaft beginning 26.8 cm from the distal end of the connector shaft.No other visual damage was noted.Impedance testing showed an electrical open at the proximal wave form.Image testing could not be performed due to the condition of the device.

Event Description

It was reported that catheter issue occurred.The patient presented with a peripheral artery disease on the lower limb.Vascular access was obtained utilizing the arm and ipsilateral approach using the common femoral artery.The totally occluded target lesion was located in the moderately tortuous and mildly calcified iliac artery.The opticross 18 imaging catheter was advanced for ultrasound examination of the target lesion through the ipsilateral side.During the procedure, the catheter was stuck near the lesion while imaging.Vibration was felt at the hand base side of the catheter while the motor drive unit was moving and then the image was lost.The device was removed, and the tip was wavy, and kinks were noted.The procedure was completed with another of the same device.There was no patient injury reported.

• Brand Name: OPTICROSS 18
• Type of Device: 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: 17597569
• MDR Text Key: 321692370
• Report Number: 2124215-2023-45217
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 44021
• Device Catalogue Number: 44021
• Device Lot Number: 0031557450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1