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 04/18/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis.Visual inspection revealed no issues and the device appeared to be in good conditions.The rotator and imaging core assembly were pulled out from the removed hub and imaging core (ic) windup was noted beginning 1.70 cm from the distal end of the connector shaft.No other visual damages were encountered.Impedance inspection revealed an electrical open at the proximal wave form.Microscopic inspection revealed the imaging window was perforated.Functional testing indicated that the catheter leaked from the imaging window section.

Event Description

Reportable based on device analysis completed on 18nov2022.It was reported that visualization issues occurred.The 98% stenosed, 20 x 3.0mm target lesion was located in the moderately tortuous and calcified left anterior descending artery.The opticross hd imaging catheter was advanced for ultrasound examination of the target lesion but could not show the image.The priming was abnormal.The procedure was completed with another of the same device.There were no patient complications and the patient condition following the procedure was stable.However, device analysis revealed a perforated 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: 15883360
• MDR Text Key: 305930400
• Report Number: 2124215-2022-49880
• 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: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2022
• Device Model Number: 8668
• Device Catalogue Number: 8668
• Device Lot Number: 0028232335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2021
• 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: 42 YR
• Patient Sex: Male
• Patient Weight: 86 KG