MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS 18; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number 44021

Device Problems Unable to Obtain Readings (1516); 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 05/23/2023

Event Type  malfunction  

Event Description

It was reported that device entrapment occurred.The lesion was mildly tortuous and mildly calcified vessel.An opticross 18 catheter was used for ultrasound examination of the target lesion.During preparation, there was no image available, and a weird noise was noticed as well.However, the catheter twisted back on itself and broke.The device was removed intact from the patient.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.Visual inspection revealed that the sheath and the imaging window were kinked, and a catheter twist began 7cm from the lap joint section.The telescope was in good conditions and no signs of detachments, or any other damages were noticed.Microscopic inspection revealed that the guidewire exit port was deformed, but the tip was in good condition.A catheter twist was observed.Impedance testing showed an electrical open at the proximal wave form.A test guidewire was inserted and no indication of resistance while tracking the guidewire into of the catheter was noted.Based on the x-ray images, the electrical failure was a result of a broken coax cable at 130-140 cm.

Event Description

It was reported that device entrapment occurred.The lesion was mildly tortuous and mildly calcified vessel.An opticross 18 catheter was used for ultrasound examination of the target lesion.During the procedure when the catheter was turned on, there was no image and a weird noise occurred.Shortly after, the catheter twisted back on itself and broke.The device was removed intact from the patient.The procedure was completed with another of the same device.No patient complications were reported.

Event Description

It was reported that device entrapment occurred.The lesion was mildly tortuous and mildly calcified vessel.An opticross 18 catheter was used for ultrasound examination of the target lesion.During the procedure when the catheter was turned on, there was no image and a weird noise occurred.Shortly after, the catheter twisted back on itself and broke.The device was removed intact from the patient.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: OPTICROSS 18
• 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: 17138503
• MDR Text Key: 317265670
• Report Number: 2124215-2023-30914
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 08714729904366
• UDI-Public: 08714729904366
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160514
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 44021
• Device Catalogue Number: 44021
• Device Lot Number: 0031317936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2023
• 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