MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS 35; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number H7493932801350

Device Problems Detachment of Device or Device Component (2907); Material Integrity Problem (2978); Material Twisted/Bent (2981)

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

Event Date 02/12/2024

Event Type  malfunction  

Event Description

It was reported that catheter issue occurred.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel.The opticross 35 imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the procedure, the physician purged the ivus catheter, then advanced it on a non-bsc (boston scientific) 260cm hydrophilic guide.However, upon removing the ivus catheter, it got stuck on the guidewire and could not be removed.This resulted in the catheter losing its shape and breaking in the middle third.The ivus catheter and the guidewire had to be removed as one unit and the guidewire was not able to be removed from the device once outside patient.The procedure was completed with an alternative method.There were no patient complications reported.

Event Description

It was reported that catheter issue occurred.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel.The opticross 35 imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the procedure, the physician purged the ivus catheter, then advanced it on a non-bsc (boston scientific) 260cm hydrophilic guide.However, upon removing the ivus catheter, it got stuck on the guidewire and could not be removed.This resulted in the catheter losing its shape and breaking in the middle third.The ivus catheter and the guidewire had to be removed as one unit and the guidewire was not able to be removed from the device once outside patient.The procedure was completed with an alternative method.There were no patient complications reported.

Manufacturer Narrative

The media returned by the customer does not show any evidence of the reported catheter material twist.However, the guidewire lumen (sheath) was damaged.Based on the evidence, the reported code of imaging window twist cannot be confirmed, while the sheath damage can be confirmed.

• Brand Name: OPTICROSS 35
• 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: 18839677
• MDR Text Key: 336956721
• Report Number: 2124215-2024-12543
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H7493932801350
• Device Catalogue Number: H7493932801350
• Device Lot Number: 0032867398
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2023
• 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
• Treatment: 260CM HYDROPHILIC GUIDE; 260CM HYDROPHILIC GUIDE
• Patient Age: 48 YR
• Patient Sex: Female