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

Model Number 8668

Device Problems Poor Quality Image (1408); Retraction Problem (1536); Device Displays Incorrect Message (2591)

Patient Problem Non specific EKG/ECG Changes (1817)

Event Date 02/16/2023

Event Type  Injury  

Event Description

It was reported that st elevation occurred.The target lesion was located in a mildly tortuous and moderately calcified no stenosis left anterior descending artery (lad), no stenosis circumflex (cx), and 70% stenosed left main (lm) before the rotablation.After left main rotablation completed, the opticross hd catheter used to check the result.After washing the catheter several times, the catheter was inserted into the lad, the pullback started but the image was incomprehensible.Then, the pullback stopped, and error message appeared "the image cannot be ealuated".The circumflex (cx) was the same and st elevation was noted.The physician removed the device and the procedure canceled.The patient was stable post procedure.

Manufacturer Narrative

Device evaluated by manufacturer: visual inspection of the device revealed that the telescope and the sheath were observed kinked.No damages or failures were observed on the ccp (catheter code pcba) board assembly.Microscopic inspection noted pitting and degradation of the transducer housing consistent with saline damage.The mdu and ilab system were used to perform a functional inspection on the device.The catheter was properly recognized by the imaging system when plugged into the mdu and no connection issues or errors were detected during its testing.It was observed that the catheter flushed normally when the imaging core was fully retracted and fully advanced.Imaging core impedance test shows a complete circuit curve.Transducer level impedance test shows a good rh peak of 40 ohms.During image characterization testing, a good square image appeared in the ilab system.Auto pullback was not performed with the sled due to the kink in the telescope.The telescope assembly was able to properly pull back, advance, and retract; however, some resistance was found due to the kink in the telescope.Inspection of the remainder of the device, revealed no other damage or irregularities.

Event Description

It was reported that st elevation occurred.The target lesion was located in a mildly tortuous and moderately calcified no stenosis left anterior descending artery (lad), no stenosis circumflex (cx), and 70% stenosed left main (lm) before the rotablation.After left main rotablation completed, the opticross hd catheter used to check the result.After washing the catheter several times, the catheter was inserted into the lad, the pullback started but the image was incomprehensible.Then, the pullback stopped, and error message appeared "the image cannot be evaluated".The circumflex (cx) was the same and st elevation was noted.The physician removed the device and the procedure canceled.The patient was stable post procedure.

• Brand Name: OPTICROSS HD
• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16486698
• MDR Text Key: 310709762
• Report Number: 2124215-2023-10318
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: HU
• 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
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2023
• Device Model Number: 8668
• Device Catalogue Number: 8668
• Device Lot Number: 0030307612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2022
• 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): Other
• Patient Age: 55 YR
• Patient Sex: Male