OPTICROSS? HD
Report
- Report Number
- 2124215-2025-31098
- Event Type
- Death
- Date Received
- May 22, 2025
- Date of Event
- April 24, 2025
- Report Date
- July 31, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- OBJ
- UDI-DI
- 08714729960737
- PMA / PMN Number
- K173284
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION REVEALED NO ISSUES, AND THE DEVICE APPEARED TO BE IN GOOD CONDITION. THE FLUSHING ACCESSORIES WERE NOT RETURNED FOR ANALYSIS. FUNCTIONAL INSPECTION OF THE MOTOR DRIVE UNIT (MDU) AND ILAB SYSTEM SHOWED THAT THE CATHETER FLUSHED NORMALLY WHEN THE TELESCOPE WAS FULLY RETRACTED AND FULLY ADVANCED. AN IMPEDANCE TEST SHOWED NO ELECTRICAL ISSUES. A CLEAR SQUARE IMAGE APPEARED ON THE ILAB SYSTEM DURING IMAGE CHARACTERIZATION TESTING. DURING THE FLUSH TEST, NO AIR BUBBLES REMAINED INSIDE THE CATHETER AFTER FLUSHING, AND NO SIGNS OF LEAKAGE WERE OBSERVED. G4: PREMARKET / 510(K) # K173284, K213593. H6 IMPACT CODES: CORRECTED.
G4: PREMARKET / 510(K) # K173284, K213593.
IT WAS REPORTED THAT A PATIENT DEATH OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE DISTAL LEFT MAIN CORONARY ARTERY. THE OPTICROSS HD IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) OF THE TARGET LESION. AS THE PHYSICIAN ATTEMPTED TO PASS THE IVUS CATHETER ACROSS THE LESION, IMAGING WAS ACTIVATED AND AN ARTIFACT WAS OBSERVED ON THE SCREEN. THE TECHNICIAN WAS ASKED WHETHER FLUSHING WAS OCCURRING, AND THEY CONFIRMED THAT IT WAS. THE TECHNICIAN WAS THEN INSTRUCTED TO STOP FLUSHING, AND THE PHYSICIAN AND TECHNICIAN DECIDED TO REMOVE AND RE-PREP THE CATHETER. THE PHYSICIAN NOTED ELEVATED ST-SEGMENTS, AND CONTRAST INJECTION REVEALED A SLOW-FLOW PHENOMENON. A DECISION WAS MADE TO ASPIRATE THE LEFT ANTERIOR DESCENDING ARTERY (LAD). ASPIRATION WAS PERFORMED, WHICH RESTORED SOME FLOW TO THE PROXIMAL LAD. HOWEVER, THE PATIENTS CONDITION WORSENED, AND THEY WENT INTO CARDIAC ARREST WITH PULSELESS ELECTRICAL ACTIVITY (PEA). CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED, AND A PERCUTANEOUS LEFT VENTRICULAR ASSIST DEVICE (LVAD) WAS INSERTED. CORONARY ANGIOGRAPHY PERFORMED AFTER IMPELLA PLACEMENT SHOWED NORMAL CORONARY FLOW. DESPITE EFFORTS, THE PATIENT DIED FOLLOWING A PROLONGED PEA ARREST. POST-PROCEDURE INSPECTION OF THE CATHETER REVEALED AIR IN THE CLEAR LUMEN. IT WAS NOTED THAT THE SUPPLIED EXTENSION TUBING HAD NOT BEEN USED; INSTEAD, TUBING FROM A DIFFERENT MANUFACTURER HAD BEEN CONNECTED TO THE BOSTON SCIENTIFIC STOPCOCK AND SYRINGES. THE PHYSICIAN BELIEVED THAT IMPROPER CATHETER PREPARATION LED TO AN AIR EMBOLISM. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT.
IT WAS REPORTED THAT A PATIENT DEATH OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE DISTAL LEFT MAIN CORONARY ARTERY. THE OPTICROSS HD IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) OF THE TARGET LESION. AS THE PHYSICIAN ATTEMPTED TO PASS THE IVUS CATHETER ACROSS THE LESION, IMAGING WAS ACTIVATED AND AN ARTIFACT WAS OBSERVED ON THE SCREEN. THE TECHNICIAN WAS ASKED WHETHER FLUSHING WAS OCCURRING, AND THEY CONFIRMED THAT IT WAS. THE TECHNICIAN WAS THEN INSTRUCTED TO STOP FLUSHING, AND THE PHYSICIAN AND TECHNICIAN DECIDED TO REMOVE AND RE-PREP THE CATHETER. THE PHYSICIAN NOTED ELEVATED ST-SEGMENTS, AND CONTRAST INJECTION REVEALED A SLOW-FLOW PHENOMENON. A DECISION WAS MADE TO ASPIRATE THE LEFT ANTERIOR DESCENDING ARTERY (LAD). ASPIRATION WAS PERFORMED, WHICH RESTORED SOME FLOW TO THE PROXIMAL LAD. HOWEVER, THE PATIENTS CONDITION WORSENED, AND THEY WENT INTO CARDIAC ARREST WITH PULSELESS ELECTRICAL ACTIVITY (PEA). CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED, AND A PERCUTANEOUS LEFT VENTRICULAR ASSIST DEVICE (LVAD) WAS INSERTED. CORONARY ANGIOGRAPHY PERFORMED AFTER IMPELLA PLACEMENT SHOWED NORMAL CORONARY FLOW. DESPITE EFFORTS, THE PATIENT DIED FOLLOWING A PROLONGED PEA ARREST. POST-PROCEDURE INSPECTION OF THE CATHETER REVEALED AIR IN THE CLEAR LUMEN. IT WAS NOTED THAT THE SUPPLIED EXTENSION TUBING HAD NOT BEEN USED; INSTEAD, TUBING FROM A DIFFERENT MANUFACTURER HAD BEEN CONNECTED TO THE BOSTON SCIENTIFIC STOPCOCK AND SYRINGES. THE PHYSICIAN BELIEVED THAT IMPROPER CATHETER PREPARATION LED TO AN AIR EMBOLISM. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2321571 | OPTICROSS? HD | CATHETER, ULTRASOUND, INTRAVASCULAR | OBJ | BOSTON SCIENTIFIC CORPORATION | H74939352040 | 0034705159 | 08714729960737 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Death |