CROSSER CTO RECANALIZATION CATHETER
Report
- Report Number
- 2020394-2016-01209
- Event Type
- Malfunction
- Date Received
- December 28, 2016
- Date of Event
- November 21, 2016
- Report Date
- November 30, 2016
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DQY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
BARD BECAME AWARE OF A JOURNAL ARTICLE PUBLISHED BY THE JAPANESE ASSOCIATION OF CARDIOVASCULAR INTERVENTION AND THERAPEUTICS 2016, TITLED 'EVALUATION FOR THE EFFICACY AND SAFETY OF THE CROSSER CATHETER AS A CTO CROSSING DEVICE AND A FLOSSING DEVICE'. A RESPONSE TO THE REQUEST FOR ADDITIONAL INFORMATION IDENTIFIED THAT MDR # 2020394-2015-00717, # 2020394-2015-00771, AND # 2020394-2015-00748 WERE ASSOCIATED WITH THE ARTICLE REVIEWED AND SUMMARIZED IN MDR # 2020394-2016-01209. 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. JOURNAL ARTICLE REVIEW: THE STUDY EVALUATED THE EFFICACY AND SAFETY OF THE CROSSER CATHETER USED AS A CTO CROSSING DEVICE; AS WELL AS, A FLOSSING DEVICE. TWO CRITERIA WERE SET FOR THE EVALUATION OF STUDY: PRIMARY TECHNICAL SUCCESS WAS DEFINED AS SUCCESSFUL DELIVERY OF THE DEVICE INTO THE DISTAL TRUE LUMEN OF THE ARTERY AND SUCCESSFUL REVASCULARIZATION OF A CTO (CHRONIC TOTAL OCCLUSION) OF THE ARTERY (DEFINED AS A 100% OCCLUSION IN THE ARTERY WITH NO DETECTABLE ANTI-GRADE FLOW DURING A CONTRAST INJECTED ARTERIAL GRAM, THE ARTERY WAS OCCLUDED FOR MORE THAN THREE MONTHS BASED ON THE PATIENT¿S HISTORY). PATIENTS WITH ACUTE LIMB ISCHEMIA WERE EXCLUDED FROM THE STUDY. THE OVERALL PRIMARY TECHNICAL SUCCESS RATE WAS 93.3% (6 PATIENTS, THE CROSSER CATHETER DID NOT PASS THE CTO LESION). SECONDARY TECHNICAL SUCCESS WAS DEFINED AS SUCCESSFUL REVASCULARIZATION; REVASCULARIZATION WAS DEFINED AS LESS THAN 30% RESIDUAL STENOSIS AT THE TARGET LESION POST PROCEDURE. THE OVERALL SECONDARY TECHNICAL SUCCESS RATE WAS 96.7% (3 PATIENTS, VESSEL REVASCULARIZATION WAS NOT ACHIEVED). THE DEGREE OF LESION CALCIFICATION WAS CATEGORIZED USING THE PROPOSED PERIPHERAL ARTERIAL CALCIUM SCORING SYSTEM (PACSS); GRADE 0 WAS DEFINED AS NO VISIBLE CALCIUM AT THE TARGET LESION, GRADE ONE WAS DEFINED AS UNILATERAL CALCIFICATION LESS THAN 5 CM, REDUCE FIND AS UNILATERAL CALCIFICATION MORE THAN 5 CM, GREAT THREE WAS DEFINED AS BILATERAL CONSULTATION LESS THAN 5 CM AND GREAT FOR WAS DEFINED AS BILATERAL CALCIFICATION MORE THAN 5 CM. IN ALL OF THE 90 PATIENT CASE STUDIES WHERE A PTA BALLOON WAS USED, SUCCESSFULLY CROSSED THE CTO LESION FOLLOWING THE USE OF THE CROSSER CATHETER. DETACHMENT OF THE DISTAL TIP OF THE CROSSER CATHETER: OCCURRED IN 14.4% OF THE PATIENT¿S. SLOW BLOOD FLOW POST CROSSER CATHETER: OCCURRED IN 4.4% OF THE PATIENT¿S. ARTERIAL DISSECTIONS: NO PATIENT OCCURRENCE WAS EXPERIENCED. ARTERIAL PERFORATIONS: NO PATIENT OCCURRENCE WAS EXPERIENCED. THE CROSSER CATHETER WAS USED AS A CROSS IN DEVICE IN 41.1% CASES AND WAS USED AS A FLOSSING DEVICE IN 58.9% CASES. OVERALL PRIMARY TECHNICAL SUCCESS RATE WAS 93.3%. OF THE FOUR COMPLICATIONS EVALUATED; TIP DETACHMENT (14.4% OCCURRENCE), SLOW FLOW IN THE ARTERY (4.4% OCCURRENCE), VESSEL PERFORATION (0% OCCURRENCE) AND VESSEL DISSECTION (0% OCCURRENCE). THE STUDY CONCLUDED: PACSS GRADE 4 WAS A PREDICTOR OF DISTAL TIP DETACHMENT. THE PHYSICIANS WHO PERFORM THE STUDY OBSERVED THE TIP DETACHMENT OCCURRED WHEN THE OPERATOR CONTINUED TO PUSH IT DESPITE THE PROXIMAL SHAFT BEING TRAPPED BY THE TIGHT LESION. AN OBSERVATION OF THE SHAFT BECOMING STUCK MAY BE DUE TO THE DIFFERENCE IN PROFILE FROM THE METAL TIP (1.1 MM) AND THE PROXIMAL SHAFT (1.3 MM). THE STUDY SUGGESTED A USEFUL PREVENTION FOR TIP DETACHMENT; PERFORM PTA BALLOON ANGIOPLASTY FOR CREATION SPACE IN THE PROXIMAL PART OF THE LESIONS PRIOR TO ADVANCING THE CROSSER CATHETER. BECAUSE THERE WERE ONLY FOR CASES WHICH IDENTIFIED SLOW FLOW STUDY WAS UNABLE TO ANALYZE PREDICTORS FOR THIS PHENOMENON. BASED ON THE EXPERIENCE FROM THE PHYSICIAN¿S ADMINISTRATION OF DRUGS SUCH AS NITROPRUSSIDE, ASPIRATION, AND PEDAL ARCH ANGIOPLASTY PERFORMED WERE EFFECTIVE FOR OVERCOMING THESE SITUATIONS. THERE WERE NO OCCURRENCES OF VESSEL PERFORATION OR DISSECTION. THE STUDY CONCLUDED THAT BECAUSE A .014 WIRE WAS USED PRECEDING THE CROSSER CATHETER IN 97.2% OF THE PROCEDURES PERFORMED, CONTRIBUTED TO THE VERY HIGH SUCCESS RATE OF ADVANCING THE CROSSER CATHETER INTO THE DISTAL TRUE LUMEN AND SUCCESSFUL REVASCULARIZATION OF THE ARTERY AT 93.3% AND 96.7% RESPECTIVELY. THE STUDY ALSO INDICATED THAT A GUIDEWIRE PRECEDING THE CROSSER CATHETER MAY HAVE CONTRIBUTED A 0% OCCURRENCE OF VESSEL PERFORATION OR VESSEL DISSECTION. TAN, M., URASAWA, K., KOSHIDA, R., HARAGUCHI, T., KITANI, S., NAKAGAWA, Y., ¿ SATO, K. (2016). EVALUATION FOR THE EFFICACY AND SAFETY OF THE CROSSER CATHETER AS A CTO CROSSING DEVICE AND A FLOSSING DEVICE. JAPANESE ASSOCIATION OF CARDIOVASCULAR INTERVENTION AND THERAPEUTICS. DOI:10.1007/S12928-016-0444-7. IMAGE REVIEW: BASED ON THE IMAGES PROVIDED, A GUIDEWIRE PRECEDED THE CROSSER CATHETER AND WAS ADVANCED THROUGH AN OCCLUDED DISTAL SFA/POPLITEAL ARTERY, CAN BE CONFIRMED. BASED ON THE IMAGES PROVIDED, IT IS UNKNOWN IF THE OCCLUDED DISTAL SFA/POPLITEAL ARTERY WAS PATENT WITH REVASCULARIZATION OF THE SFA/POPLITEAL ARTERY AT THE CONCLUSION OF THE PROCEDURE. BASED ON THE IMAGES PROVIDED, A SEPARATION BETWEEN THE DISTAL TIP AND THE CROSSER CATHETER IN THE POPLITEAL ARTERY CAN BE CONFIRMED. BASED ON THE IMAGES PROVIDED, IT IS UNKNOWN IF THE ENTIRE CROSSER CATHETER WAS REMOVED FROM THE PATIENT. BASED ON THE IMAGES PROVIDED, IT IS UNKNOWN IF REVASCULARIZATION OF THE POPLITEAL ARTERY WAS ACHIEVED. CONCLUSION: THE DEVICE WAS NOT RETURNED. IMAGES WERE PROVIDED. BASED UPON THE IMAGES PROVIDED TWO OF THE REPORTED DEVICES CAN BE CONFIRMED FOR MATERIAL SEPARATION HOWEVER THE REMAINING EIGHT ARE INCONCLUSIVE AS THE DEVICES WERE NOT RETURNED AND IMAGES WERE NOT PROVIDED. THE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. IT IS UNKNOWN WHETHER PATIENT AND/OR PROCEDURAL FACTORS CONTRIBUTED TO THE EVENT. LABELING REVIEW: THE CURRENT INSTRUCTIONS FOR USE (IFU) STATES: WARNINGS AND PRECAUTIONS: WHEN USING THE CROSSER IN TORTUOUS ANATOMY, THE USE OF A SUPPORT CATHETER IS RECOMMENDED TO PREVENT KINKING OR PROLAPSE OF THE CROSSER CATHETER TIP. KINKING OR PROLAPSE OF THE TIP COULD CAUSE CATHETER BREAKAGE AND/OR MALFUNCTION. ADVERSE EVENTS: 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/HYPOTENSION, INFECTION OR FEVER, ALLERGIC REACTION, PSEUDOANEURYSM OR FISTULA ANEURYSM, ACUTE RECLOSURE, THROMBOSIS, ISCHEMIC EVENTS, DISTAL EMBOLIZATION, EXCESSIVE CONTRAST LOAD RESULTING IN RENAL INSUFFICIENCY OR FAILURE, EXCESSIVE EXPOSURE TO RADIATION, STROKE/CVA, RESTENOSIS, REPEAT CATHETERIZATION / ANGIOPLASTY, PERIPHERAL ARTERY BYPASS, AMPUTATION, DEATH OR OTHER BLEEDING COMPLICATIONS AT ACCESS SITE. INTERVENTIONAL USE: SLOWLY ADVANCE THE CATHETER TIP THROUGH THE LESION. APPLY STEADY, CONSTANT PRESSURE SO THE TIP OF THE CATHETER IS ENGAGED TO THE LESION. UPON SUCCESSFUL RECANALIZATION OF THE LESION, ADVANCE THE GUIDEWIRE DISTAL TO THE LESION AND THEN WITHDRAW THE CROSSER CATHETER S6 FROM THE BODY AND ADVANCE A GUIDEWIRE THROUGH THE LESION." ADDITIONAL MFR NARRATIVE: REPORT SOURCE, DATE RECEIVED BY MFR. DESCRIBE EVENT OR PROBLEM, EVALUATION CODES (PATIENT), (DEVICE), (CONCLUSION). 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 HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER. A JOURNAL ARTICLE WITH IMAGES WAS RECEIVED AND REVIEWED. AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS NOT BEING PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. JOURNAL ARTICLE REVIEW: THE STUDY EVALUATED THE EFFICACY AND SAFETY OF THE CROSSER CATHETER USED AS A CTO CROSSING DEVICE; AS WELL AS, A FLOSSING DEVICE. TWO CRITERIA WERE SET FOR THE EVALUATION OF STUDY: PRIMARY TECHNICAL SUCCESS WAS DEFINED AS SUCCESSFUL DELIVERY OF THE DEVICE INTO THE DISTAL TRUE LUMEN OF THE ARTERY AND SUCCESSFUL REVASCULARIZATION OF A CTO (CHRONIC TOTAL OCCLUSION) OF THE ARTERY (DEFINED AS A 100% OCCLUSION IN THE ARTERY WITH NO DETECTABLE ANTI-GRADE FLOW DURING A CONTRAST INJECTED ARTERIAL GRAM, THE ARTERY WAS OCCLUDED FOR MORE THAN THREE MONTHS BASED ON THE PATIENT¿S HISTORY). PATIENTS WITH ACUTE LIMB ISCHEMIA WERE EXCLUDED FROM THE STUDY. THE OVERALL PRIMARY TECHNICAL SUCCESS RATE WAS 93.3% (6 PATIENTS, THE CROSSER CATHETER DID NOT PASS THE CTO LESION). SECONDARY TECHNICAL SUCCESS WAS DEFINED AS SUCCESSFUL REVASCULARIZATION; REVASCULARIZATION WAS DEFINED AS LESS THAN 30% RESIDUAL STENOSIS AT THE TARGET LESION POST PROCEDURE. THE OVERALL SECONDARY TECHNICAL SUCCESS RATE WAS 96.7% (3 PATIENTS, VESSEL REVASCULARIZATION WAS NOT ACHIEVED). THE DEGREE OF LESION CALCIFICATION WAS CATEGORIZED USING THE PROPOSED PERIPHERAL ARTERIAL CALCIUM SCORING SYSTEM (PACSS); GRADE 0 WAS DEFINED AS NO VISIBLE CALCIUM AT THE TARGET LESION, GRADE ONE WAS DEFINED AS UNILATERAL CALCIFICATION LESS THAN 5 CM, REDUCE FIND AS UNILATERAL CALCIFICATION MORE THAN 5 CM, GREAT THREE WAS DEFINED AS BILATERAL CONSULTATION LESS THAN 5 CM AND GREAT FOR WAS DEFINED AS BILATERAL CALCIFICATION MORE THAN 5 CM. IN ALL OF THE 90 PATIENT CASE STUDIES WHERE A PTA BALLOON WAS USED, SUCCESSFULLY CROSSED THE CTO LESION FOLLOWING THE USE OF THE CROSSER CATHETER. DETACHMENT OF THE DISTAL TIP OF THE CROSSER CATHETER: OCCURRED IN 14.4% OF THE PATIENT¿S. SLOW BLOOD FLOW POST CROSSER CATHETER: OCCURRED IN 4.4% OF THE PATIENT¿S. ARTERIAL DISSECTIONS: NO PATIENT OCCURRENCE WAS EXPERIENCED. ARTERIAL PERFORATIONS: NO PATIENT OCCURRENCE WAS EXPERIENCED. THE CROSSER CATHETER WAS USED AS A CROSS IN DEVICE IN 41.1% CASES AND WAS USED AS A FLOSSING DEVICE IN 58.9% CASES. OVERALL PRIMARY TECHNICAL SUCCESS RATE WAS 93.3%. OF THE FOUR COMPLICATIONS EVALUATED; TIP DETACHMENT (14.4% OCCURRENCE), SLOW FLOW IN THE ARTERY (4.4% OCCURRENCE), VESSEL PERFORATION (0% OCCURRENCE) AND VESSEL DISSECTION (0% OCCURRENCE). THE STUDY CONCLUDED: PACSS GRADE 4 WAS A PREDICTOR OF DISTAL TIP DETACHMENT. THE PHYSICIANS WHO PERFORM THE STUDY OBSERVED THE TIP DETACHMENT OCCURRED WHEN THE OPERATOR CONTINUED TO PUSH IT DESPITE THE PROXIMAL SHAFT BEING TRAPPED BY THE TIGHT LESION. AN OBSERVATION OF THE SHAFT BECOMING STUCK MAY BE DUE TO THE DIFFERENCE IN PROFILE FROM THE METAL TIP (1.1 MM) AND THE PROXIMAL SHAFT (1.3 MM). THE STUDY SUGGESTED A USEFUL PREVENTION FOR TIP DETACHMENT; PERFORM PTA BALLOON ANGIOPLASTY FOR CREATION SPACE IN THE PROXIMAL PART OF THE LESIONS PRIOR TO ADVANCING THE CROSSER CATHETER. BECAUSE THERE WERE ONLY FOR CASES WHICH IDENTIFIED SLOW FLOW STUDY WAS UNABLE TO ANALYZE PREDICTORS FOR THIS PHENOMENON. BASED ON THE EXPERIENCE FROM THE PHYSICIAN¿S ADMINISTRATION OF DRUGS SUCH AS NITROPRUSSIDE, ASPIRATION, AND PEDAL ARCH ANGIOPLASTY PERFORMED WERE EFFECTIVE FOR OVERCOMING THESE SITUATIONS. THERE WERE NO OCCURRENCES OF VESSEL PERFORATION OR DISSECTION. THE STUDY CONCLUDED THAT BECAUSE A .014 WIRE WAS USED PRECEDING THE CROSSER CATHETER IN 97.2% OF THE PROCEDURES PERFORMED, CONTRIBUTED TO THE VERY HIGH SUCCESS RATE OF ADVANCING THE CROSSER CATHETER INTO THE DISTAL TRUE LUMEN AND SUCCESSFUL REVASCULARIZATION OF THE ARTERY AT 93.3% AND 96.7% RESPECTIVELY. THE STUDY ALSO INDICATED THAT A GUIDEWIRE PRECEDING THE CROSSER CATHETER MAY HAVE CONTRIBUTED A 0% OCCURRENCE OF VESSEL PERFORATION OR VESSEL DISSECTION. TAN, M., URASAWA, K., KOSHIDA, R., HARAGUCHI, T., KITANI, S., NAKAGAWA, Y., ¿ SATO, K. (2016). EVALUATION FOR THE EFFICACY AND SAFETY OF THE CROSSER CATHETER AS A CTO CROSSING DEVICE AND A FLOSSING DEVICE. JAPANESE ASSOCIATION OF CARDIOVASCULAR INTERVENTION AND THERAPEUTICS. DOI:10.1007/S12928-016-0444-7. IMAGE REVIEW: A TOTAL OF FOUR IMAGES WERE INCLUDED AS PART OF THE 90 PATIENT STUDY PUBLISHED. BASED ON THE IMAGES PROVIDED, A DETACHED DISTAL TIP OF THE CROSSER CATHETER CAN BE CONFIRMED; HOWEVER, THE REMOVAL OF THE DETACHED DISTAL TIP OF THE CROSSER CATHETER CANNOT BE CONFIRMED. BASED ON THE IMAGES PROVIDED, A GUIDEWIRE PRECEDED THE CROSSER CATHETER AND WAS ADVANCED THROUGH AN OCCLUDED DISTAL SFA/POPLITEAL ARTERY, CAN BE CONFIRMED. HOWEVER, IT IS UNKNOWN IF THE OCCLUDED DISTAL SFA/POPLITEAL ARTERY REVASCULARIZATION WAS ACHIEVED AT THE CONCLUSION OF THE PROCEDURE CAN BE CONFIRMED. CONTRAST INJECTION DEMONSTRATED SOME BLOOD FLOW THROUGH THE OCCLUDED DISTAL SFA/POPLITEAL ARTERY CAN BE CONFIRMED. 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 IN A MEDICAL JOURNAL ARTICLE, JAPANESE ASSOCIATION OF CARDIOVASCULAR INTERVENTION AND THERAPEUTICS 2016, TITLED 'EVALUATION FOR THE EFFICACY AND SAFETY OF THE CROSSER CATHETER AS A CTO CROSSING DEVICE AND A FLOSSING DEVICE'. A 90 PATIENT CLINICAL STUDY WITH A HISTORY OF PERIPHERAL ARTERIAL DISEASE IN THE FEMORAL POPLITEAL ARTERY EXTENDING TO THE FOOT. THE STUDY WAS BASED ON THE SUCCESS RATE OF THE CROSSER CATHETER ADVANCEMENT INTO THE TRUE LUMEN OF THE ARTERY (93.3%) AND SUCCESSFUL REVASCULARIZATION (96.7%) OF A CHRONIC TOTAL OCCLUDED ARTERY. A TOTAL OF 97% OF THE PROCEDURES PERFORMED USED A .014 GUIDE WIRE PRECEDING THE CROSSER CATHETER DURING ADVANCEMENT TO THE FEMORAL POPLITEAL ARTERY AND DURING ACTIVATION IN A CTO (CHRONIC TOTAL OCCLUSION) OF THE FEMORAL POPLITEAL ARTERY. UPON COMPLETION OF THE STUDY THERE WERE NO REPORTED PERFORATIONS OR DISSECTIONS OF THE ARTERY; HOWEVER, 13 DISTAL TIP DETACHMENTS OF THE CROSSER CATHETER WERE IDENTIFIED.
IT WAS REPORTED IN A MEDICAL JOURNAL ARTICLE, JAPANESE ASSOCIATION OF CARDIOVASCULAR INTERVENTION AND THERAPEUTICS 2016, TITLED 'EVALUATION FOR THE EFFICACY AND SAFETY OF THE CROSSER CATHETER AS A CTO CROSSING DEVICE AND A FLOSSING DEVICE'. A 90 PATIENT CLINICAL STUDY WITH A HISTORY OF PERIPHERAL ARTERIAL DISEASE IN THE FEMORAL POPLITEAL ARTERY EXTENDING TO THE FOOT. THE STUDY WAS BASED ON THE SUCCESS RATE OF THE CROSSER CATHETER ADVANCEMENT INTO THE TRUE LUMEN OF THE ARTERY (93.3%) AND SUCCESSFUL REVASCULARIZATION (96.7%) OF A CHRONIC TOTAL OCCLUDED ARTERY. A TOTAL OF 97% OF THE PROCEDURES PERFORMED USED A .014 GUIDE WIRE PRECEDING THE CROSSER CATHETER DURING ADVANCEMENT TO THE FEMORAL POPLITEAL ARTERY AND DURING ACTIVATION IN A CTO (CHRONIC TOTAL OCCLUSION) OF THE FEMORAL POPLITEAL ARTERY. UPON COMPLETION OF THE STUDY THERE WERE NO REPORTED PERFORATIONS OR DISSECTIONS OF THE ARTERY, 13 DISTAL TIP DETACHMENTS OF THE CROSSER CATHETER WERE IDENTIFIED AND FOUR (4) PATIENTS HAD SLOW BLOOD FLOW PRIOR TO POST ANGIOPLASTY WHICH CREATED PATENT BLOOD FLOW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 860496 | CROSSER CTO RECANALIZATION CATHETER | RECANALIZATION CATHETER | DQY | BARD PERIPHERAL VASCULAR, INC. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | ASPIRIN, THIENOPYRIDINE, CILOSTAZOL, WARFARIN |