MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. SION BLACK; PTCA GUIDE WIRE

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]; observe movement of this guide wire in the vessels.Before this guide wire is moved or torqued, the tip movement should be examined and monitored under fluoroscopy.Do not move or torque the guide wire without observing corresponding movement of the tip; otherwise, the guide wire may be damaged and/or trauma may occur.In addition, ensure that the distal tip of this guide wire and its location in the vessel are visible during manipulations of the guide wire.Never push, auger, withdraw, or torque this guide wire that meets resistance.Torquing or pushing this guide wire against resistance may cause damage and/or tip separation of this guide wire or direct damage to a vessel.Resistance may be felt and/or observed under fluoroscopy by noting any buckling of the guide wire.If the prolapse of the guide wire tip is observed, do not allow the tip to remain in a prolapsed position; otherwise damage to the guide wire may occur.Determine the cause of resistance under fluoroscopy and take any necessary remedial action.If resistance is felt due to spasm, bending of the guide wire, or due to trap while operating this guide wire in the blood vessel or removing it, do not torque and/or pull the guide wire itself.Stop the procedure.Determine the cause of resistance under fluoroscopy and take appropriate remedial action.If the guide wire is moved excessively, it may break or become damaged, which may cause blood vessel injury or result in fragments being left inside the vessel.Use this guide wire carefully as the guide wire may penetrate the blood vessel.Otherwise, it may cause adverse events such as blood vessel perforation and coronary artery dissection.The higher torque performance, stiffer distal end, and/or higher advancement force may present a higher risk of perforation or injury than if using a more flexible guide wire.Therefore, use the most flexible guide wire that will treat the lesion (i.E., the guide wire with the smallest tip load that will treat the lesion), and take due care to minimize the risk of perforation or other damage to blood vessels.[malfunction and adverse effects]: damage to a vessel, including possible vessel perforation, vessel dissection, cardiac tamponade due to vessel perforation, thrombus.

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: SION BLACK
• Type of Device: PTCA GUIDE WIRE
• 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: 11234926
• MDR Text Key: 228828932
• Report Number: 3003775027-2021-00016
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K173277
• 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

• 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
• Initial Date Manufacturer Received: 01/12/2021
• Initial Date FDA Received: 01/27/2021
• 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