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 12/18/2023

Event Type  malfunction  

Manufacturer Narrative

A2 age at time of event: 18 years or older.E1: initial reporter facility name - (b)(6).

Event Description

It was reported that visualization issue occurred.The 75% stenosed target lesion was located in a moderately tortuous mid left anterior descending artery.The opticross imaging catheter was selected for ultrasound examination of the target lesion, but there was no image displayed during preparation.Due to this, the procedure was cancelled.There was no patient injury.

Event Description

It was reported that visualization issue occurred.The 75% stenosed target lesion was located in a moderately tortuous mid left anterior descending artery.The opticross imaging catheter was selected for ultrasound examination of the target lesion, but there was no image displayed during preparation.Due to this, the procedure was cancelled.There was no patient injury.It was further reported that the procedure was completed.

Manufacturer Narrative

A2 age at time of event: 18 years or older.E1: initial reporter facility name - (b)(6).H6 impact codes: corrected.

• 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: 18470296
• MDR Text Key: 332744390
• Report Number: 2124215-2023-75118
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• 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: 0032330456
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2023
• 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
• Patient Sex: Male