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

Model Number 8668

Device Problem Unable to Obtain Readings (1516)

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

Event Date 12/30/2021

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(6) 2022.It was reported that visualization issues occurred.The 85% stenosed, 20 x 3.00mm, target lesion was located in the moderately tortuous and moderately calcified left circumflex artery.The opticross hd imaging catheter was advanced for ultrasound examination of the target lesion.The catheter was recognized by the system and motor but could not show the image.The procedure was completed with another of the same device.There were no patient complications reported and the patient condition following the procedure was stable.However, device analysis revealed imaging window detachment near the lapjoint.

Manufacturer Narrative

Visual inspection of the returned device revealed kinks in the sheath and imaging window assembly.A broken drive shaft and imaging core windup were found within the telescope section of the device, beginning 26.5cm from the distal end of the connector shaft.Impedance testing showed an electrical open at the proximal wave form.Microscopic inspection revealed the imaging window detached near the lapjoint section.Pitting and degradation of the transducer housing was noted consistent with saline damage which occurs post-use of the device and is not related to the original device failure.Inspection of a picture provided by the site revealed the sheath and imaging window kinked and the imaging window detached near the lapjoint section.

• Brand Name: OPTICROSS HD
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13776561
• MDR Text Key: 288097162
• Report Number: 2134265-2022-02978
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 08714729960768
• UDI-Public: 08714729960768
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K173284
• 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
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2022
• Device Model Number: 8668
• Device Catalogue Number: 8668
• Device Lot Number: 0027916454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2021
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 60 KG