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

Model Number 44021

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907); Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/08/2024

Event Type  Injury  

Event Description

It was reported that the catheter issue occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified left common iliac artery.The opticross imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure, treatment was performed via a contralateral approach.A 4fr sheath was retrogradely punctured from the inguinal region on the same side as the treatment site.A guidewire was manipulated to penetrate in a bidirectional manner.After pre-dilation inside the vessel, when the physician deployed the stent from the contralateral side without removing the device from the sheath outside the patient, the tip of the device got caught between the vessel wall and stent strut.The physician attempted to remove the device, but since it was stuck in the stent strut, it could not be easily extracted.As the physician pulled strongly, it became separated.Upon fluoroscopic examination, it could not be confirmed.Another observation was made using another device of the same type, and it was confirmed that the device had become caught between the stent and blood vessel, and the separated catheter tip was flowing in the blood vessel lumen.Since the separated part was small, the physician concluded that there would be no problem, and the procedure was completed as planned.No patient injury was reported.

Event Description

It was reported that the catheter issue occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified left common iliac artery.The opticross imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure, treatment was performed via a contralateral approach.A 4fr sheath was retrogradely punctured from the inguinal region on the same side as the treatment site.A guidewire was manipulated to penetrate in a bidirectional manner.After pre-dilation inside the vessel, when the physician deployed the stent from the contralateral side without removing the device from the sheath outside the patient, the tip of the device got caught between the vessel wall and stent strut.The physician attempted to remove the device, but since it was stuck in the stent strut, it could not be easily extracted.As the physician pulled strongly, it became separated.Upon fluoroscopic examination, it could not be confirmed.Another observation was made using another device of the same type, and it was confirmed that the device had become caught between the stent and blood vessel, and the separated catheter tip was flowing in the blood vessel lumen.Since the separated part was small, the physician concluded that there would be no problem, and the procedure was completed as planned.No patient injury was reported.

Manufacturer Narrative

D2b: pro code (product code): corrected.

Event Description

Iit was reported that the catheter issue occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified left common iliac artery.The opticross imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure, treatment was performed via a contralateral approach.A 4fr sheath was retrogradely punctured from the inguinal region on the same side as the treatment site.A guidewire was manipulated to penetrate in a bidirectional manner.After pre-dilation inside the vessel, when the physician deployed the stent from the contralateral side without removing the device from the sheath outside the patient, the tip of the device got caught between the vessel wall and stent strut.The physician attempted to remove the device, but since it was stuck in the stent strut, it could not be easily extracted.As the physician pulled strongly, it became separated.Upon fluoroscopic examination, it could not be confirmed.Another observation was made using another device of the same type, and it was confirmed that the device had become caught between the stent and blood vessel, and the separated catheter tip was flowing in the blood vessel lumen.Since the separated part was small, the physician concluded that there would be no problem, and the procedure was completed as planned.No patient injury was reported.

Manufacturer Narrative

The device was returned for analysis.Visual and microscope inspection revealed the sheath assembly was kinked, and the tip was detached.The tip was not returned for analysis.Based on the evidence, the as reported codes of tip detached and catheter stuck in stent are confirmed,.

Event Description

It was reported that the catheter issue occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified left common iliac artery.The opticross imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure, treatment was performed via a contralateral approach.A 4fr sheath was retrogradely punctured from the inguinal region on the same side as the treatment site.A guidewire was manipulated to penetrate in a bidirectional manner.After pre-dilation inside the vessel, when the physician deployed the stent from the contralateral side without removing the device from the sheath outside the patient, the tip of the device got caught between the vessel wall and stent strut.The physician attempted to remove the device, but since it was stuck in the stent strut, it could not be easily extracted.As the physician pulled strongly, it became separated.Upon fluoroscopic examination, it could not be confirmed.Another observation was made using another device of the same type, and it was confirmed that the device had become caught between the stent and blood vessel, and the separated catheter tip was flowing in the blood vessel lumen.Since the separated part was small, the physician concluded that there would be no problem, and the procedure was completed as planned.No patient injury was 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: 18789910
• MDR Text Key: 336350360
• Report Number: 2124215-2024-11594
• Device Sequence Number: 1
• Product Code: ITX
• 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,Followup
• Report Date: 03/20/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 44021
• Device Catalogue Number: 44021
• Device Lot Number: 0032377435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2023
• 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 Outcome(s): Required Intervention; Other