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

Model Number 44021

Device Problems Entrapment of Device (1212); Positioning Problem (3009)

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

Event Date 05/02/2023

Event Type  malfunction  

Event Description

It was reported that device entrapment occurred.The patient presented with peripheral artery disease for left 0ower extremity angiogram, atherectomy and angioplasty.The target lesion had parts with greater than 90% stenosis, and was located in the severely calcified and non-tortuous distal anterior tibial artery.The opticross 18 imaging catheter was selected for ultrasound examination of the target lesion.When live image was activated, it appeared the transducer tried to rotate slightly, but then stopped.When an attempt was made to start a second time, the same thing occurred.When the physician tried to remove the device.Both the catheter and guidewire had to be removed together as a unit.The procedure was completed with another of the same device.There were no patient complications.

Manufacturer Narrative

The device was returned for analysis.Visual inspection revealed the tip was stuck on the floppy end of the guidewire, there were kinks in the sheath assembly, and the imaging window and imaging core were twisted.Microscopic inspection revealed the guidewire exit port was damaged (deformed/lifted).The imaging core rotate test was not performed due to the state in which the device was returned.

Event Description

It was reported that device entrapment occurred.The patient presented with peripheral artery disease for left power extremity angiogram, atherectomy and angioplasty.The target lesion had parts with greater than 90% stenosis and was located in the severely calcified and non-tortuous distal anterior tibial artery.The opticross 18 imaging catheter was selected for ultrasound examination of the target lesion.When live image was activated, it appeared the transducer tried to rotate slightly but then stopped.When an attempt was made to start a second time, the same thing occurred.When the physician tried to remove the device, both the catheter and guidewire had to be removed together as a unit.The procedure was completed with another of the same device.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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 16989473
• MDR Text Key: 315840500
• Report Number: 2124215-2023-25780
• 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,Followup
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• 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: 0031164199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: 0.014 TERUMO EXTRA FLOPPY GUIDEWIRE.; 0.014 TERUMO EXTRA FLOPPY GUIDEWIRE.
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Race: Black Or African American