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

Model Number 8655

Device Problems Difficult to Flush (1251); Material Deformation (2976); Material Integrity Problem (2978)

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

Event Date 01/03/2024

Event Type  malfunction  

Manufacturer Narrative

E1 initial reporter facility name: (b)(6) hospital.

Event Description

It was reported that a catheter issue occurred.The target lesion was located in a 95% stenosed, moderately tortuous and moderately calcified left anterior descending artery.An opticross imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure, it was noted that the catheter was kinked and fractured.The procedure was completed by using another of the same device.There were no patient complications reported.

Event Description

It was reported that a catheter issue occurred.The target lesion was located in a 95% stenosed, moderately tortuous and moderately calcified left anterior descending artery.An opticross imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure, it was noted that the catheter was kinked and fractured.The procedure was completed by using another of the same device.There were no patient complications reported.

Manufacturer Narrative

E1 initial reporter facility name: (b)(6).The device was returned for analysis.Visual inspection revealed the telescope and imaging window were kinked.Based on the evidence, the as reported codes of catheter damaged/defective and catheter kink are confirmed.

• Brand Name: OPTICROSS
• 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: 18677111
• MDR Text Key: 336067446
• Report Number: 2124215-2024-07477
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 08714729890393
• UDI-Public: 08714729890393
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K161125
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0032082817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2023
• 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 Age: 69 YR
• Patient Sex: Male
• Patient Weight: 85 KG