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

Model Number 8668

Device Problems Poor Quality Image (1408); Device Displays Incorrect Message (2591); Detachment of Device or Device Component (2907)

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

Event Date 06/10/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that sheath detachment occurred.The 75% stenosed, 33 x 2.75mm target lesion was located in the moderately tortuous and mildly calcified distal left circumflex artery.The opticross hd imaging catheter was selected for use but during flushing, overload occurred three times along with dark image.The device was introduced to view the lesion but resistance increased while advancing the catheter to the distal part of the lesion.The image was not normal so the catheter was pulled back and found to be detached in the guide catheter.The detached part was removed together with the guide catheter without adverse effect to the patient.The procedure was completed with another of the same device.

Event Description

It was reported that sheath detachment occurred.The 75% stenosed, 33 x 2.75mm target lesion was located in the moderately tortuous and mildly calcified distal left circumflex artery.The opticross hd imaging catheter was selected for use but during flushing, overload occurred three times along with dark image.The device was introduced to view the lesion but resistance increased while advancing the catheter to the distal part of the lesion.The image was not normal so the catheter was pulled back and found to be detached in the guide catheter.The detached part was removed together with the guide catheter without adverse effect to the patient.The procedure was completed with another of the same device.

Manufacturer Narrative

E1 initial reporter facility: (b)(6).E1 initial reporter city: (b)(6).The device was returned for analysis.Visual inspection revealed imaging window detachment.Friction marks were found between the rotator and retainer clip.The rotator and imaging core assembly were pulled out from hub.No imaging core windup was found within the telescope section and the sheath section of the device.The tip and guidewire exit port were in good condition.Impedance testing shows an electrical open at proximal.Based on the x-ray images, the electrical failure was a result of a broken coaxial cable.A test guidewire was inserted and no indication of resistance in tracking the guidewire into of the catheter was noted.The catheter was properly recognized by the imaging system when plugged into the motor drive unit and no connection issues or errors were detected during testing.

• Brand Name: OPTICROSS HD
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12105103
• MDR Text Key: 259638898
• Report Number: 2134265-2021-08468
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2022
• Device Model Number: 8668
• Device Catalogue Number: 8668
• Device Lot Number: 0027241194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Date Manufacturer Received: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 69