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U.S. Department of Health and Human Services

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

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ASAHI INTECC CO., LTD. ASAHI CORSAIR PERCUTANEOUS CATHETER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Myocardial Infarction (1969); Rupture (2208)
Event Type  Injury  
Manufacturer Narrative

Manufacturing site: manufacturing site could not be determined because the product lot number information was not available. Device evaluation could not be performed because the device was not returned. Investigation of production records and adverse events data could not be performed because lot information was unavailable. Although the device investigation and lot history review could not be conducted, all the shipped products were inspected in the production process for meeting the product specifications and release criteria; therefore, it was concluded there was no indication of product deficiency. It was inferred that anatomical condition and/or device manipulation technique most likely contributed to the reported adverse events. Instructions for use (ifu) states: warnings- if any resistance or something abnormal is felt when operating this product, do not continue the operation while the causes are unclear. If it is suspected that the product is not operating correctly, avoid excessive manipulations, and carefully remove the entire catheter system while paying full attention to avoid complications. (continuing the operation while the cause of the problem is not identified may cause damage to or separation of the catheter, and damage the blood vessel. Life-threatening adverse events may occur). Warning]-the microcatheter must always be operated under high-resolution fluoroscopic guidance. Particular attention should be paid when inserting or withdrawing the microcatheter into stenotic areas and narrower vessels than the product. (abrasion may result in damage or separation of the microcatheter. This may cause vascular injury and perforation, possibly leading to a life-threatening adverse event). Warnings- do not insert the guide wire by force or advance it rapidly when the microcatheter is bent or twisted. Such manipulations may cause breakage or damage of the microcatheter, or perforation of the blood vessel; and, malfunction and adverse effects- death, perforation of blood vessels, and infarction.

 
Event Description

According to literature titled "optimal use of fielder xt guidewire enhances the success rate of chronic total occlusion percutaneous coronary intervention" in world journal of clinical cases 2019 april 26; 7(8): 928-939, multiple devices including asahi products were used in this study. Death, coronary artery rupture, major adverse cardiovascular events, and post-procedural myocardial infarction were mentioned that unspecified patients involved in this study had experienced; which device had contributed to the reported adverse patient effects were unspecified. The results of this study were written as follows: "in total, 1230 patients were recruited; 75. 4% of the patients were male, and 55. 8% of the patients were in the xt group. The overall success rate was 83. 9%, with 87. 8% in the xt group. Based on multivariate logistic regression analysis, factors positively associated with procedural success were the use of fielder xt guidewire (p = 0. 005, 95%ci: 1. 172-2. 380) and systolic blood pressure (p = 0. 011, 95%ci: 1. 003-1. 022), while factors negatively associated with procedural success were blunt stump (p = 0. 013, 95%ci: 1. 341-11. 862), male sex (p = 0. 016, 95%ci: 0. 363-0. 902), new york heart association (nyha) class (p = 0. 035, 95%ci: 0. 553-0. 979), contrast amount (p = 0. 018, 95%ci: 0. 983-0. 998) and occlusion time (p = 0. 009, 95%ci: 0. 994-0. 999). No significant differences were found between the xt group and the no-xt group with respect to clinical parameters, lesion-related characteristics, coronary artery rupture [3 (0. 4%) vs 8 (1. 5%), p = 0. 056], in-hospital death [2 (0. 3%) vs 6 (1. 1%), p = 0. 079] or in-hospital target lesion revascularization [3 (0. 4%) vs 7 (1. 3%), p < 0. 099]. However, there were significant differences between the groups with respect to success rate [602 (87. 8%) vs 430 (79. 0%), p < 0. 001], procedure time [(74 쳌} 23) vs (83 쳌} 21), p < 0. 001], stent length [(32. 0 쳌} 15. 8) vs (37. 3 쳌} 17. 6), p < 0. 001], contrast amount [(148 쳌} 46) vs (166 쳌} 43), p < 0. 001], post-pci myocardial infarction [43 (6. 3%) vs 59 (10. 8%), p = 0. 004], major adverse cardiovascular event [44 (6. 4%) vs 57 (10. 7%), p = 0. 007], side branch loss [31 (4. 5%) vs 44 (8. 1%), p = 0. 009], contrast-induced nephropathy [29 (4. 2%) vs 40 (7. 4%), p = 0. 018] and no reflow [8 (1. 2%) vs 14 (2. 9%), p = 0. 034]. ".

 
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Brand NameASAHI CORSAIR
Type of DevicePERCUTANEOUS CATHETER
Manufacturer (Section D)
ASAHI INTECC CO., LTD.
3-100 akatsuki-cho
seto, 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 Key8770190
MDR Text Key150365525
Report Number3003775027-2019-00115
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberUNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/18/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/09/2019
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/18/2019
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 TREATMENT DATA
Date Received: 07/09/2019 Patient Sequence Number: 1
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