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

Model Number 44021

Device Problems Poor Quality Image (1408); Material Deformation (2976); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009); Physical Resistance/Sticking (4012)

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

Event Date 10/16/2023

Event Type  malfunction  

Event Description

It was reported that catheter issue occurred.The 56% stenosed target lesion was located in moderately tortuous and mildly calcified arteriovenous fistula in the arm.The opticross peripheral imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure, the catheter spun on itself and kinked at the distal end, thus no longer providing an image.The device was removed intact.After trying to manually unkink the catheter, the device was prepped once more but the transducer was not rotating, and no image was visible.The procedure was completed with another of same device.There were no patient complications.

Manufacturer Narrative

G2 report source: corrected.

Event Description

It was reported that catheter issue occurred.The 56% stenosed target lesion was located in moderately tortuous and mildly calcified arteriovenous fistula in the arm.The opticross peripheral imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure, the catheter spun on itself and kinked at the distal end, thus no longer providing an image.The device was removed intact.After trying to manually unkink the catheter, the device was prepped once more but the transducer was not rotating, and no image was visible.The procedure was completed with another of same device.There were no patient complications.It was further reported that the access site was located in the left brachial artery.An 11 cm sheath and.018 thruway guidewire were placed.The opticross catheter was being monitored on fluoroscopy and failed while navigating through the left upper arm arteriovenous fistula.When the catheter was being advanced, resistance was encountered and when imaging was turned on, the catheter spun and kinked on itself.It was also noted that the guidewire kinked.The operator removed the whole system at once and gained wire access with a new wire.

Event Description

It was reported that catheter issue occurred.The 56% stenosed target lesion was located in moderately tortuous and mildly calcified arteriovenous fistula in the arm.The opticross peripheral imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure, the catheter spun on itself and kinked at the distal end, thus no longer providing an image.The device was removed intact.After trying to manually unkink the catheter, the device was prepped once more but the transducer was not rotating, and no image was visible.The procedure was completed with another of same device.There were no patient complications.It was further reported that the access site was located in the left brachial artery.An 11 cm sheath and.018 thruway guidewire were placed.The opticross catheter was being monitored on fluoroscopy and failed while navigating through the left upper arm arteriovenous fistula.When the catheter was being advanced, resistance was encountered and when imaging was turned on, the catheter spun and kinked on itself.It was also noted that the guidewire kinked.The operator removed the whole system at once and gained wire access with a new wire.

Manufacturer Narrative

The device was returned for analysis.Visual inspection revealed kinks in the sheath and imaging window assembly, and catheter twisting beginning 13 cm from the lap joint section.There was also a broken drive shaft within the telescope section of the device, beginning at the distal end of the connector shaft.No other visual damages were encountered upon visual inspection.Microscopic inspection revealed the guidewire exit port and tip were deformed.Impedance testing showed an electrical open at the proximal end of the catheter.A test guidewire was inserted and no indication of resistance in tracking the guidewire into the catheter was noted.Auto pullback was performed with the sled correctly, and the telescope was fully retracted and fully advanced without- any issues.

• 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 shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18086756
• MDR Text Key: 328069528
• Report Number: 2124215-2023-61809
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• 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: 0032043646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2023
• 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