OPTICROSS? 6 HD
Report
- Report Number
- 2124215-2025-41570
- Event Type
- Injury
- Date Received
- June 27, 2025
- Date of Event
- May 30, 2025
- Report Date
- August 21, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- OBJ
- UDI-DI
- 08714729960775
- PMA / PMN Number
- K173820
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
G4: PREMARKET / 510(K) # K173820, K213593 GOOD FAITH EFFORTS ARE BEING MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT.
G4: PREMARKET / 510(K) # K173820, K213593.
G4: PREMARKET / 510(K) # K173820, K213593. THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION REVEALED THE SHEATH WAS KINKED. IMPEDANCE TESTING SHOWED AN ELECTRICAL OPEN AT THE DISTAL END OF THE CATHETER BETWEEN 1-10 CM FROM THE DISTAL HOUSING. THE DEVICE FLUSHED NORMALLY WHEN THE TELESCOPE WAS FULLY RETRACTED AND FULLY ADVANCED WITH NO SIGNS OF LEAKAGE.
IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS 6 HD IMAGING CATHETER WAS FLUSHED THREE TIMES PRIOR TO BEING ADVANCED FOR AN INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING PULLBACK, THE STAFF NOTICED A DARK IMAGE AND SUSPECTED THE PRESENCE OF AIR IN THE CATHETER. THE DEVICE WAS FLUSHED WHILE STILL IN THE BODY. NO AIR EMBOLISM WAS OBSERVED, ALTHOUGH THE PATIENT EXHIBITED SYMPTOMS COMMONLY ASSOCIATED WITH ONE. THE DEVICE WAS REMOVED, FLUSHED MULTIPLE TIMES, AND THEN REINSERTED. THE STAFF AGAIN OBSERVED THE SAME DARK IMAGE. THE DEVICE WAS REMOVED ONCE MORE AND FLUSHED. THE PATIENT EXPERIENCED HYPOTENSION AND BRADYCARDIA, WHICH RESOLVED WITHIN 15 MINUTES. MEDICATIONS WERE GIVEN TO STABILIZE BLOOD PRESSURE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THE PATIENT MADE A FULL RECOVERY AND THERE WERE NO OTHER PATIENT COMPLICATIONS.
IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS 6 HD IMAGING CATHETER WAS FLUSHED THREE TIMES PRIOR TO BEING ADVANCED FOR AN INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING PULLBACK, THE STAFF NOTICED A DARK IMAGE AND SUSPECTED THE PRESENCE OF AIR IN THE CATHETER. THE DEVICE WAS FLUSHED WHILE STILL IN THE BODY. NO AIR EMBOLISM WAS OBSERVED, ALTHOUGH THE PATIENT EXHIBITED SYMPTOMS COMMONLY ASSOCIATED WITH ONE. THE DEVICE WAS REMOVED, FLUSHED MULTIPLE TIMES, AND THEN REINSERTED. THE STAFF AGAIN OBSERVED THE SAME DARK IMAGE. THE DEVICE WAS REMOVED ONCE MORE AND FLUSHED. THE PATIENT EXPERIENCED HYPOTENSION AND BRADYCARDIA, WHICH RESOLVED WITHIN 15 MINUTES. MEDICATIONS WERE GIVEN TO STABILIZE BLOOD PRESSURE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THE PATIENT MADE A FULL RECOVERY AND THERE WERE NO OTHER PATIENT COMPLICATIONS.
IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS 6 HD IMAGING CATHETER WAS FLUSHED THREE TIMES PRIOR TO BEING ADVANCED FOR AN INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING PULLBACK, THE STAFF NOTICED A DARK IMAGE AND SUSPECTED THE PRESENCE OF AIR IN THE CATHETER. THE DEVICE WAS FLUSHED WHILE STILL IN THE BODY. NO AIR EMBOLISM WAS OBSERVED, ALTHOUGH THE PATIENT EXHIBITED SYMPTOMS COMMONLY ASSOCIATED WITH ONE. THE DEVICE WAS REMOVED, FLUSHED MULTIPLE TIMES, AND THEN REINSERTED. THE STAFF AGAIN OBSERVED THE SAME DARK IMAGE. THE DEVICE WAS REMOVED ONCE MORE AND FLUSHED. THE PATIENT EXPERIENCED HYPOTENSION AND BRADYCARDIA, WHICH RESOLVED WITHIN 15 MINUTES. MEDICATIONS WERE GIVEN TO STABILIZE BLOOD PRESSURE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THE PATIENT MADE A FULL RECOVERY AND THERE WERE NO OTHER PATIENT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2096640 | OPTICROSS? 6 HD | CATHETER, ULTRASOUND, INTRAVASCULAR | OBJ | BOSTON SCIENTIFIC CORPORATION | H74939354080 | 0036171646 | 08714729960775 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |