MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. CORSAIR; PERCUTANEOUS CATHETER

Device Problem Insufficient Information (3190)

Patient Problems Hematoma (1884); Perforation of Vessels (2135); Cardiac Tamponade (2226); Vascular Dissection (3160); Thrombosis/Thrombus (4440)

Event Type  Death  

Manufacturer Narrative

Manufacturing site was unable to be identified because lot information was unavailable.Device evaluation could not be performed because the affected device was not returned.Lot history records review could not be conducted because lot information was unavailable.All the shipped products were inspected in the production process and satisfied the product specifications and release criteria; therefore, it was concluded that there was no anomaly in product quality.Multiple asahi products were used in this study; however, how each mentioned product had cause or contributed to macce was unable to be determined based on the limited written information.Referring to known similar events, it was presumed that patient anatomy and procedural contents were most likely associated with adverse events occurred during this study.It was concluded that this event was not attributed to product quality.Instructions for use (ifu) states: [warnings] if any resistance or something abnormal is felt when operating this microcatheter, do not continue the manipulation while the causes are unclear.If it is suspected that this microcatheter is not operating correctly, avoid excessive manipulations, and carefully remove the entire catheter system while paying full attention to avoid complications.(continuing the manipulation while the cause of the problem is not identified may cause damage to this microcatheter, and damage the blood vessel.) this microcatheter must always be operated under high-resolution fluoroscopic guidance.Particular attention should be paid when inserting or withdrawing this microcatheter into or through stenotic areas, and narrower vessels than the microcatheter.(abrasion may result in damage of this microcatheter.This may cause vascular injury and perforation.) [malfunctions and adverse effects].Death.Vessel dissection or perforation.Hemorrhage or hematoma.Embolization or fragmentation of thrombotic or atherosclerotic material.

Event Description

It was reported through a research article titled "incidence, predictors, and strategies for failure of retrograde microcatheter tracking after successful wiring of septal collateral channels in chronic total occlusions (clinical interventions in aging 2020:15 1727-1735)" that identified asahi products: sion, fielder xt-r, sion black and corsair may be related to in-hospital major adverse cardiac and cerebral events (macce).Excerpt is as follows: in total, 298 patients with cto who underwent retrograde septal cc pci between january 2015 and may 2019 were retrospectively analyzed.Clinical data were compared to investigate the predictors of initial microcatheter tracking failure.The initial and final microcatheter tracking success rates were 79.2% (236/298) and 96.6% (288/298), respectively.The procedural success rate was 94.0% (280/298).The overall initial microcatheter cc tracking failure was 20.8%.Severe collateral tortuosity, cc entry, and exit angle of <90 degrees, use of finecross mg as initial microcatheter, and shunning initial retrograde application of guidezilla were variables independently associated with initial microcatheter cc tracking failure in patients with cto undergoing retrograde septal pci.The sion guidewire was used for the initial guidewire cc tracking and the initial guidewire success rate was 78.5% (234/298).Among the 64 patients who failed initial guidewire tracking, the guidewire was switched to fielder xt-r or sion black.Finally, the guidewire was passed through the cc to the distal end of the occluded segment in all 64 individuals.We found no significant differences in the initial guidewire success rate between the failure and successful groups (72.6% vs 80.1%, p=0.224).Of the 28 patients who failed in retrograde pci, 10 successfully received antegrade pci.The final procedural success rate was 94.0% (280/298), with a direct guidewire passing rate of 5.4% (15/280), antegrade pci rate of 3.6% (10/290), kissing wire passing rate of 11.4% (32/280), and reverse cart success rate of 79.6% (223/ 280).We found no significant differences in the incidence rates of procedural complications and in-hospital macces.Five (2.1%) and two patients (3.2%) in the successful and failure groups, respectively, developed donor vessel dissection, of whom three (1.3%) and one patient (1.6%) had stents implantation, respectively.Septal hematoma occurred in two (0.8%) and one patient (1.6%) in the successful and failure groups, respectively.Three patients (1.3%) in the successful group developed target vessel perforation, and 2 (0.8%) developed acute cardiac tamponade, of whom 1 (0.4%) died after treatment failure.One patient (1.6%) in the failure group developed target vessel perforation and died after treatment failure.Three patients (1.3%) in the successful group developed acute in-stent thrombosis and underwent target-vessel revascularization, of whom one (0.4%) who had a refractory hypotension died in the hospital.One patient (1.6%) in the failure group developed acute in-stent thrombosis, and symptoms were alleviated after target-vessel revascularization.The rca to lad septal ratio (48.4% vs 33.1%, p=0.037) and cc tortuosity (34.6% vs 20.8%, p=0.045) in the initial microcatheter cc tracking failure group were significantly higher than those in the successful group.Corsair appeared in figure 3 clinical management of microcatheter collateral channel tracking.

• Brand Name: CORSAIR
• Type of Device: PERCUTANEOUS CATHETER
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• Manufacturer (Section G): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• Manufacturer Contact: yukako homma ; 3-100 akatsuki-cho; seto, aichi 489-0-071 ; JA 489-0071
• MDR Report Key: 11234934
• MDR Text Key: 228827627
• Report Number: 3003775027-2021-00018
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K171933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention