OPTICROSS 18
Report
- Report Number
- 2124215-2025-20636
- Event Type
- Injury
- Date Received
- April 9, 2025
- Date of Event
- March 11, 2025
- Report Date
- June 23, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- OBJ
- UDI-DI
- 08714729904366
- PMA / PMN Number
- K160514
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
G4-PREMARKET / 510(K) #: K160514, K222568. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE ARE STILL WAITING TO OBTAIN THE INFORMATION THROUGH GOOD FAITH EFFORT. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
CORRECTION REPORT IS BEING FILED TO UPDATE H6 (DEVICE CODES). G4-PREMARKET / 510(K) #: K160514, K222568. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. PER THE SOURCE, THIS INFORMATION WAS NOT AVAILABLE. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. PER THE SOURCE, THIS INFORMATION WAS NOT AVAILABLE. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE OPTICROSS 18 WAS NOT RETURNED BUT DEVICE ANALYSIS WAS PERFORMED USING THE PHOTO RECEIVED. THE MEDIA ATTACHED SHOWS THE ISSUES OF CATHETER TWIST AND DETACHMENT.
CORRECTION REPORT IS BEING FILED TO UPDATE H6 (IMPACT CODES). G4-PREMARKET / 510(K) #: K160514, K222568 DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. PER THE SOURCE, THIS INFORMATION WAS NOT AVAILABLE. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IT WAS REPORTED THAT THE CATHETER BECAME TANGLED AND SEPARATED, REQUIRING INTERVENTION. AN OPTICROSS 18 VASCULAR IMAGING CATHETER WAS USED FOR A PERIPHERAL INTERVENTION PROCEDURE FOR ARTERIAL DISEASE. DURING THE PROCEDURE, THE CATHETER TWISTED AROUND ITSELF IN THE BODY AND THEN SEPARATED. THE PROCEDURE WAS NOT COMPLETED, AND THE PATIENT WAS THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT THE CATHETER BECAME TANGLED AND SEPARATED, REQUIRING INTERVENTION. AN OPTICROSS 18 VASCULAR IMAGING CATHETER WAS USED FOR A PERIPHERAL INTERVENTION PROCEDURE FOR ARTERIAL DISEASE. DURING THE PROCEDURE, THE CATHETER TWISTED AROUND ITSELF IN THE BODY AND THEN SEPARATED. THE PROCEDURE WAS NOT COMPLETED, AND THE PATIENT WAS ALREADY SEDATED WITH GENERAL ANESTHESIA. THE PATIENT WAS TRANSPORTED TO A NEARBY HOSPITAL TO REMOVE THE CATHETER THROUGH SURGERY AND WAS ADMITTED TO THE HOSPITAL. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT THE CATHETER BECAME TANGLED AND SEPARATED, REQUIRING INTERVENTION. AN OPTICROSS 18 VASCULAR IMAGING CATHETER WAS USED FOR A PERIPHERAL INTERVENTION PROCEDURE FOR ARTERIAL DISEASE. DURING THE PROCEDURE, THE CATHETER TWISTED AROUND ITSELF IN THE BODY AND THEN SEPARATED. THE PROCEDURE WAS NOT COMPLETED, AND THE PATIENT WAS ALREADY SEDATED WITH GENERAL ANESTHESIA. THE PATIENT WAS TRANSPORTED TO A NEARBY HOSPITAL TO REMOVE THE CATHETER THROUGH SURGERY AND WAS ADMITTED TO THE HOSPITAL. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT THE CATHETER BECAME TANGLED AND SEPARATED, REQUIRING INTERVENTION. AN OPTICROSS 18 VASCULAR IMAGING CATHETER WAS USED FOR A PERIPHERAL INTERVENTION PROCEDURE FOR ARTERIAL DISEASE. DURING THE PROCEDURE, THE CATHETER TWISTED AROUND ITSELF IN THE BODY AND THEN SEPARATED. THE PROCEDURE WAS NOT COMPLETED, AND THE PATIENT WAS ALREADY SEDATED WITH GENERAL ANESTHESIA. THE PATIENT WAS TRANSPORTED TO A NEARBY HOSPITAL TO REMOVE THE CATHETER THROUGH SURGERY AND WAS ADMITTED TO THE HOSPITAL. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1664327 | OPTICROSS 18 | CATHETER, ULTRASOUND, INTRAVASCULAR | OBJ | BOSTON SCIENTIFIC CORPORATION | H7493932800180 | 08714729904366 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |