OPTICROSS? 6 HD
Report
- Report Number
- 2124215-2024-78368
- Event Type
- Malfunction
- Date Received
- December 12, 2024
- Date of Event
- December 5, 2024
- Report Date
- April 14, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- OBJ
- PMA / PMN Number
- K173820
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PMA 510(K): K173820, K213593. THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. HOWEVER, MEDIA PROVIDED BY THE CUSTOMER WAS REVIEWED AND FOUND TO SHOW EVIDENCE OF THE IMAGING CORE KINKED AND TWISTED AND IMAGING WINDOW, TWISTED ISSUES.
G4 PMA 510(K): K173820, K213593.
THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION REVEALED THAT THE IMAGING WINDOW AND DRIVE CABLE WERE TWISTED. MICROSCOPE INSPECTION CONFIRMED THE SAME FINDINGS AND ALSO SHOWED THAT THE GUIDEWIRE EXIT PORT WAS LIFTED AND THE DISTAL SECTION OF THE TIP WAS IN GOOD CONDITION. AN IMPEDANCE TEST INDICATED AN ELECTRICAL OPEN AT THE DISTAL END OF THE CATHETER, BETWEEN 10-20 CM FROM THE DISTAL HOUSING. MEDIA RETURNED BY THE CUSTOMER WAS ALSO REVIEWED AND SHOWED THE IMAGING WINDOW AND DRIVE CABLE WERE TWISTED. G4 PMA 510(K): K173820, K213593.
IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED DISTAL RIGHT CORONARY ARTERY. THE OPTICROSS HD IMAGING CATHETER WAS ADVANCED OVER A NON-BOSTON SCIENTIFIC GUIDEWIRE FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING INSERTION, AN IMAGING ISSUE OCCURRED, AND WHITE RINGS/DISTORTED IMAGES WERE DISPLAYED ON THE IMAGING SCREEN. IT WAS FOUND THAT THE IVUS CATHETER WAS STUCK ON THE GUIDEWIRE, AND THE PHYSICIAN SUCCESSFULLY REMOVED THE GUIDE CATHETER, GUIDEWIRE, AND OPTICROSS CATHETER TOGETHER. THE OPTICROSS WAS ALSO NOTED TO BE KINKED 10-20 CM FROM THE TIP AND FRACTURED AT THE TELESCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.
IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED DISTAL RIGHT CORONARY ARTERY. THE OPTICROSS HD IMAGING CATHETER WAS ADVANCED OVER A NON-BOSTON SCIENTIFIC GUIDEWIRE FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING INSERTION, AN IMAGING ISSUE OCCURRED, AND WHITE RINGS/DISTORTED IMAGES WERE DISPLAYED ON THE IMAGING SCREEN. IT WAS FOUND THAT THE IVUS CATHETER WAS STUCK ON THE GUIDEWIRE, AND THE PHYSICIAN SUCCESSFULLY REMOVED THE GUIDE CATHETER, GUIDEWIRE, AND OPTICROSS CATHETER TOGETHER. THE OPTICROSS WAS ALSO NOTED TO BE KINKED 10-20 CM FROM THE TIP AND FRACTURED AT THE TELESCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.
IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED DISTAL RIGHT CORONARY ARTERY. THE OPTICROSS HD IMAGING CATHETER WAS ADVANCED OVER A NON-BOSTON SCIENTIFIC GUIDEWIRE FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING INSERTION, AN IMAGING ISSUE OCCURRED, AND WHITE RINGS/DISTORTED IMAGES WERE DISPLAYED ON THE IMAGING SCREEN. IT WAS FOUND THAT THE IVUS CATHETER WAS STUCK ON THE GUIDEWIRE, AND THE PHYSICIAN SUCCESSFULLY REMOVED THE GUIDE CATHETER, GUIDEWIRE, AND OPTICROSS CATHETER TOGETHER. THE OPTICROSS WAS ALSO NOTED TO BE KINKED 10-20 CM FROM THE TIP AND FRACTURED AT THE TELESCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2062279 | OPTICROSS? 6 HD | CATHETER, ULTRASOUND, INTRAVASCULAR | OBJ | BOSTON SCIENTIFIC CORPORATION | H74939354080 | 0034912009 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | .014 TERUMO RUNTHROUGH GUIDEWIRE| .014 TERUMO RUNTHROUGH GUIDEWIRE| .014 TERUMO RUNTHROUGH GUIDEWIRE| 7F CORDIS AL.75 GUIDE CATHETER| 7F CORDIS AL.75 GUIDE CATHETER| 7F CORDIS AL.75 GUIDE CATHETER |