CROSSER CATHETER 14S
Report
- Report Number
- 2020394-2017-00266
- Event Type
- Malfunction
- Date Received
- March 29, 2017
- Date of Event
- March 18, 2015
- Report Date
- April 19, 2017
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- PDU
- UDI-DI
- 10801741125420
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
MANUFACTURING REVIEW: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A MANUFACTURING REVIEW COULD NOT BE PERFORMED. VISUAL/MICROSCOPIC INSPECTION: AS THE DEVICE WAS NOT RETURNED, AN INSPECTION COULD NOT BE PERFORMED. FUNCTIONAL/PERFORMANCE EVALUATION: AS THE DEVICE WAS NOT RETURNED, AN EVALUATION COULD NOT BE PERFORMED. MEDICAL RECORDS REVIEW: AS MEDICAL RECORDS WERE NOT PROVIDED, A REVIEW COULD NOT BE PERFORMED. ABSTRACT BOOK REVIEW: BETWEEN SEPTEMBER 2014 AND JULY 2015 81 CRITICAL LIMB ISCHEMIA (CLI) PATIENTS WERE TREATED WITH CROSSER. SUCCESSFUL RECANALIZATION WAS OBTAINED IN 94 CASES (92%). THERE WERE THREE CASES OF TIP OR CORE WIRE SEPARATION OF THE CROSSER CATHETER AND 2 CASES OF GUIDEWIRE BREAKAGE. IN THREE CASES THE TIP AND WIRE FRAGMENTS WERE RETRIEVED RETROGRADE FROM THE GROIN BY A SNARE, IN ONE CASE, THE TIP WAS RETRIEVED ANTEGRADE, AND IN THE LAST CASE, THE TIP RETRIEVAL WAS ABANDONED AS IT WAS LOCATED IN A FAR DISTAL POSITION. SATO, T. (2016). USEFULNESS AND COMPLICATIONS OF THE CROSSER SYSTEM IN HEAVILY CALCIFIED BELOW-THE-KNEE ARTERIES OF HEMODIALYSIS PATIENTS. CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, 39 (SUPPLEMENT 3), S302. DOI: 10.1007/S00270-016-1405-3 . IMAGE/PHOTO REVIEW: AS MEDICAL IMAGES WERE NOT PROVIDED, A REVIEW COULD NOT BE PERFORMED. CONCLUSION: THE DEVICE WAS NOT RETURNED FOR EVALUATION. IMAGES AND MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE USE OF DEVICE ISSUE. PER THE REPORTED EVENT, THE GUIDEWIRE WAS ADVANCED PAST THE DISTIL TIP OF THE CROSSER CATHETER DURING ACTIVATION OF THE CATHETER. PER THE IFU, AFTER ADVANCING THE GUIDEWIRE AND CROSSER CATHETER TO THE LESION SITE, THE GUIDEWIRE NEEDS TO BE WITHDRAWN APPROXIMATELY 1 CM WITHIN THE CATHETER SO THAT THE TIP OF THE CROSSER CATHETER IS THE LEADING EDGE. THEREFORE, THE GUIDEWIRE DETACHMENT IS MOST LIKELY USER RELATED. LABELING REVIEW: THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: INTERVENTIONAL USE: - FOR THE CROSSER CATHETERS 14P, 14S, AND S6, ACCESS LESION WITH STANDARD 0.014¿ (0.36 MM) GUIDEWIRE. - ADVANCE THE GUIDEWIRE AND CROSSER CATHETER 14P, 14S, OR 18 TO THE LESION SITE. WITHDRAW THE GUIDEWIRE APPROXIMATELY 1CM WITHIN THE CATHETER SO THAT THE TIP OF THE CROSSER CATHETER IS THE LEADING EDGE. - SLOWLY ADVANCE THE CATHETER TIP THROUGH THE LESION. APPLY STEADY, CONSTANT PRESSURE SO THE TIP OF THE CATHETER IS ENGAGED TO THE LESION. ADVERSE EFFECTS: AS WITH MOST PERCUTANEOUS INTERVENTIONS, POTENTIAL ADVERSE EFFECTS INCLUDE: - BLEEDING WHICH MAY REQUIRE TRANSFUSION OR SURGICAL INTERVENTION, HEMATOMA, PERFORATION, DISSECTION, GUIDEWIRE ENTRAPMENT AND/OR FRACTURE, HYPERTENSION ANEURYSM, ACUTE RECLOSURE, THROMBOSIS, ISCHEMIC EVENTS, DISTAL EMBOLIZATION, EXPOSURE TO RADIATION, STROKE/CVA, RESTENOSIS, REPEAT CATHETERIZATION / ANGIOPLASTY, PERIPHERAL ARTERY BYPASS, AMPUTATION, DEATH OR OTHER BLEEDING COMPLICATIONS AT ACCESS SITE. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.
NO HOSPITAL/MEDICAL RECORDS OR MEDICAL IMAGES HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER. AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WILL NOT BE PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. ABSTRACT BOOK REVIEW: BETWEEN SEPTEMBER 2014 AND JULY 2015 81 CRITICAL LIMB ISCHEMIA (CLI) PATIENTS WERE TREATED WITH CROSSER. SUCCESSFUL RECANALIZATION WAS OBTAINED IN 94 CASES (92%). THERE WERE THREE CASES OF TIP OR CORE WIRE SEPARATION OF THE CROSSER CATHETER AND 2 CASES OF GUIDEWIRE BREAKAGE. IN THREE CASES THE TIP AND WIRE FRAGMENTS WERE RETRIEVED RETROGRADE FROM THE GROIN BY A SNARE, IN ONE CASE, THE TIP WAS RETRIEVED ANTEGRADE, AND IN THE LAST CASE, THE TIP RETRIEVAL WAS ABANDONED AS IT WAS LOCATED IN A FAR DISTAL POSITION. SATO, T. (2016). USEFULNESS AND COMPLICATIONS OF THE CROSSER SYSTEM IN HEAVILY CALCIFIED BELOW-THE-KNEE ARTERIES OF HEMODIALYSIS PATIENTS. CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, 39 (SUPPLEMENT 3), S302. DOI: 10.1007/S00270-016-1405-3. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.
IT WAS REPORTED DURING TREATMENT OF A HEAVILY CALCIFIED LESION IN THE POPLITEAL ARTERY, A GUIDEWIRE ADVANCING BEYOND THE TIP OF A RECANALIZATION CATHETER ALLEGEDLY DETACHED WHEN THE DEVICE WAS ACTIVATED. THE DETACHED GUIDEWIRE SEGMENT WAS SUCCESSFULLY REMOVED WITH A SNARE DEVICE. NO ADDITIONAL TREATMENT WAS NEEDED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
IT WAS REPORTED DURING TREATMENT OF A HEAVILY CALCIFIED LESION IN THE POPLITEAL ARTERY, A GUIDEWIRE ADVANCING BEYOND THE TIP OF A RECANALIZATION CATHETER ALLEGEDLY DETACHED WHEN THE DEVICE WAS ACTIVATED. THE DETACHED GUIDEWIRE SEGMENT WAS SUCCESSFULLY REMOVED WITH A SNARE DEVICE. NO ADDITIONAL TREATMENT WAS NEEDED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 225435 | CROSSER CATHETER 14S | RECANALIZATION CATHETER | PDU | BARD PERIPHERAL VASCULAR, INC. | UNKNOWN | 10801741125420 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |