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

Model Number 44021

Device Problems Entrapment of Device (1212); Unable to Obtain Readings (1516); Failure to Advance (2524)

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

Event Date 04/26/2023

Event Type  malfunction  

Event Description

It was reported that entrapment occurred.The stenosed target lesion was in a normally tortuous vessel.The opticross imaging catheter was introduced for ultrasound examination of the target lesion.When the catheter was being advanced up and over the sheath at the bifurcation, a screeching noise was heard, the image went out, and the catheter became stuck on the wire inside the sheath.The devices were removed intact together.There were no patient complications.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16916090
• MDR Text Key: 315062920
• Report Number: 2124215-2023-23485
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 08714729904366
• UDI-Public: 08714729904366
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160514
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• 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: 0031167032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2023
• 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