OPTICROSS? HD
Report
- Report Number
- 2124215-2025-05695
- Event Type
- Injury
- Date Received
- February 11, 2025
- Date of Event
- January 13, 2025
- Report Date
- May 2, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- OBJ
- UDI-DI
- 08714729960737
- PMA / PMN Number
- K173284
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
D4: LOT NUMBER: UPDATED. G4: PREMARKET / 510(K) #: K173284, K213593.
THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL AND MICROSCOPE INSPECTIONS REVEALED THAT THE SHEATH WAS KINKED AND DETACHED, THE DRIVE SHAFT AND COAXIAL CABLE WERE BROKEN, THE IMAGING WINDOW AND DRIVE CABLE WERE TWISTED, AND THE IMAGING WINDOW WAS TORN. MICROSCOPE INSPECTION ALSO REVEALED THAT THE GUIDEWIRE EXIT PORT WAS LIFTED, BUT THE DISTAL SECTION OF THE TIP WAS IN GOOD CONDITION. G4: PREMARKET / 510(K) # - K173284, K213593.
IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL ARTERY. THE OPTICROSS IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE INTRAVASCULAR ULTRASOUND CATHETER TWISTED UPON ITSELF. HOWEVER, THE DEVICE WAS SUCCESSFULLY RETRIEVED. THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND THE STANDARD OF CARE.
IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL ARTERY. THE OPTICROSS IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE INTRAVASCULAR ULTRASOUND CATHETER TWISTED UPON ITSELF. HOWEVER, THE DEVICE WAS SUCCESSFULLY RETRIEVED. THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND THE STANDARD OF CARE.
IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL ARTERY. THE OPTICROSS IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE INTRAVASCULAR ULTRASOUND CATHETER TWISTED UPON ITSELF. HOWEVER, THE DEVICE WAS SUCCESSFULLY RETRIEVED. THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND THE STANDARD OF CARE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1754179 | OPTICROSS? HD | CATHETER, ULTRASOUND, INTRAVASCULAR | OBJ | BOSTON SCIENTIFIC CORPORATION | H74939352040 | 0035211509 | 08714729960737 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Male | Hospitalization |