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

Model Number 8668

Device Problem Unable to Obtain Readings (1516)

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

Event Date 09/14/2022

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 26-dec-2022.It was reported that visualization issues occurred.The 90% stenosed, 15mm in length target lesion was located in the moderately tortuous and severely calcified and 3.50mm in diameter right coronary artery.The opticross hd imaging catheter was advanced for ultrasound examination of the target lesion but could not show the image.The procedure was completed with another of the same device.No patient complications were reported and patient status was stable.However, device analysis revealed an imaging window tear.

Manufacturer Narrative

(b)(6).The device was returned for analysis.Visual inspection revealed the sheath and imaging window were kinked and a tear in the imaging window was observed.It was observed that the catheter flushed normally when the imaging core was fully retracted and fully advanced.Imaging core impedance test shows a complete circuit curve.Transducer level impedance test shows a good rh peak of 50 ohms.Image characterization testing could not be performed due to excessive damage on imaging window.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16195991
• MDR Text Key: 308583787
• Report Number: 2124215-2022-56541
• 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: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2023
• Device Model Number: 8668
• Device Catalogue Number: 8668
• Device Lot Number: 0029780534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2022
• 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
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 91 KG