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

Model Number 8668

Device Problems Difficult to Flush (1251); Poor Quality Image (1408)

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

Event Date 04/13/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis.Kinks were found at the sheath and the imaging window was noted to be partially detached near the lapjoint section.Microscopic inspection revealed pitting and degradation of the transducer housing consistent with saline damage which occurs post-use of the device and is not related to the original device failure.A flush test showed a leak though the partially detached imaging window.The imaging core impedance test showed a complete circuit curve.Impedance transducer level testing showed an electrical good rh peak signal, however, the rm value appeared too high.An image test could not be performed due to the condition in which the device returned.Although the image test was not performed, the device presented a weak transducer, which suggests that the device was no longer effective at receiving and transmitting acoustic energy at the working frequencies, caused by a shift in the resonance frequency of the transducer.

Event Description

Reportable based on device analysis completed on 20jun2022.It was reported that flushing and visualization issues occurred.The target lesion was locate din the severely tortuous and severely calcified mid left anterior descending artery.The opticross hd imaging catheter was advanced for ultrasound examination of the target lesion.Because microbubbles occurred during flushing, the device did not present a clear image.The procedure was completed with another of the same device.There were no patient complications reported and the patient condition was stable.However, device analysis revealed the imaging window was partially detached.

• Brand Name: OPTICROSS HD
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14803933
• MDR Text Key: 301362940
• Report Number: 2134265-2022-07280
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 08714729960768
• UDI-Public: 08714729960768
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2023
• Device Model Number: 8668
• Device Catalogue Number: 8668
• Device Lot Number: 0028818909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2022
• 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: 65 YR
• Patient Sex: Male