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

Model Number 8655

Device Problems Unable to Obtain Readings (1516); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 09/11/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis.Visual inspection revealed the sheath and imaging window were kinked and the imaging window and core were twisted.No imaging core windup was observed within the telescope and sheath sections of the device.Impedance testing showed an electrical open at the proximal end of the device which x-ray images showed was due to a broken coax cable at 130 cm to 140 cm.A video of the ilab system provided by the site was reviewed and showed the issue of no image.

Event Description

Reportable based on device analysis completed on (b)(6) 2023.It was reported that visualization issues occurred.The diffusive stenosed target lesion was located in the left anterior descending artery.The opticross ic imaging catheter was selected for ultrasound examination of the target lesion.After preparation, the image was dark and blood vessel structures could not be read.The device was disconnected and reconnected multiple times but there was still no image.The procedure was completed with another of the same device.There were no patient complications reported and the patient condition following the procedure was stable.However, device analysis revealed the imaging window was twisted.

• Brand Name: OPTICROSS
• 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: 18323055
• MDR Text Key: 330474789
• Report Number: 2124215-2023-70923
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 08714729890393
• UDI-Public: 08714729890393
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K161125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0031601081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 76 KG