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

Model Number 8668

Device Problems Unable to Obtain Readings (1516); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/17/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis.Visual inspection revealed the sheath was kinked and the tip and exit port were torn.Microscopic inspection also showed the marker band was detached from the tip; the marker band was not returned for analysis.It was observed that the catheter flushed normally when the imaging core was fully retracted and fully advanced.Image test could not be performed due to the condition in which the device was returned.The device showed a defective transducer, which suggests that the device was no longer effective at receiving and transmitting acoustic energy at the working frequencies.This is caused by a shift in the resonance frequency of the transducer but it was not possible to identify the issue which led to the electrical failure.

Event Description

Reportable based on analysis completed on 8nov2023.It was reported that a kink and visualization issues occurred.The 80% stenosed, 12 x 2.75 mm, target lesion was located in a moderately tortuous and moderately calcified right coronary artery.The opticross hd was selected for ultrasound examination of the target lesion.After unpacking, it was noted that the device was kinked and could not show an image.The procedure was completed with another of the same device.No patient complications were reported and the patient condition following the procedure was stable.However, device analysis results were consistent with a device that had been used, the guidewire exit port and tip were torn, and the marker band was detached.

• Brand Name: OPTICROSS HD
• 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: 18185023
• MDR Text Key: 328702229
• Report Number: 2124215-2023-65790
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 08714729960768
• UDI-Public: 08714729960768
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K173284
• 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: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8668
• Device Catalogue Number: 8668
• Device Lot Number: 0031696237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 74 KG