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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
Catalog Number CSW150-26N
Device Problem Insufficient Information (3190)
Patient Problems Intimal Dissection (1333); Fever (1858); Inflammation (1932)
Event Type  Injury  
Manufacturer Narrative

Manufacturing site: manufacturing site could not be determined because the product lot number information was not available. Device investigation could not be conducted as the subject device was not returned. Lot history review could not be conducted as lot information was unavailable. However, all shipped asahi products were inspected in the production process for meeting the product specifications and release criteria, and therefore, there was no indication of product deficiency. Several devices were used during the procedure. Information regarding how each device was used and contributed to the reported event was unavailable; therefore, it was concluded that a possibility could not be ruled out that the subject device might cause or contributed to the reported event. In this procedure, subintimal dissection / re-entry technique was used to cross the lesion. The reported patient adverse event was known as one of inherent risks of intentional vessel damaging associated with the technique. Therefore, it was concluded that this case was not related to the device quality but the operator's technique. Instructions for use states: [warnings] particular attention should be paid when inserting or withdrawing this microcatheter into or from stenotic areas and/or narrower vessels than this microcatheter. (if excessive abrasive friction occurs, damage or breakage of this microcatheter and/or vessel damage or vessel perforation may occur. ); and, [malfunctions and adverse events] bleeding complications, damage to vessel including vessel dissection, vessel perforation and vessel rupture.

 
Event Description

According to a case report "a presentation of postcardiac injury syndrome after successful chronic total occlusion percutaneous coronary intervention using dissection re-entry techniques" posted on clinical case reports (2017; 5(6): 855-858), a (b)(6) year-old male patient experienced acute pleuropericarditis after a successful pci. First procedure was implemented against a stenosis in the om branch. Two weeks after the procedure, angina was still present with medical treatment. Thus, a second intervention was taken against a calcified lesion in the proximal rca. In the procedure, antegrade approach was first taken but failed. The subject catheter was advanced retrogradely with an asahi wire in an attempt to cross the calcified cto in the rca, advancing from a septal branch through piv/pda. Subintimal dissection / re-entry technique was performed with several knuckled wires. Because of the lesion condition, wire manipulation was difficult. Finally a non-asahi wire was able to be externalized and three dess were deployed from the ostial to the lesion. No complications such as pericardial effusion during the procedure. Two hours after the procedure, the patient claimed to have chest pain but the vital signs, ecg, and echocardiogram showed no anomaly. It was then diagnosed as pericarditis. Aspirin, colchicine, and clopidogrel were prescribed and the patient was discharged home. Seven days after his discharge, the patient was re-hospitalized for severe pleuritic chest pain and a low-grade fever. Chest x-ray revealed enlarged cardiac silhouette and pleural effusion on the left side. Chest ct scan demonstrated pericardial and bilateral pleural effusions. The pleural effusion was treated with drainage system which drained more than one litter of fluid. Although small pericardial effusion was observed in the posterolateral left ventricle, normal systolic function was observed by echocardiogram. Ecg showed no abnormality. Blood tests demonstrated inflammation. The patient was then diagnosed with acute pleuropericarditis. He was treated with hydrocortisone and prednisone and recovered quickly. One month after discharge, the patient became asymptomatic. Chest x-ray shows no recurrent pleural effusion.

 
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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, 489-0 071
JA 489-0071
Manufacturer Contact
yukako homma
3-100 akatsuki-cho
seto, 489-0-071
JA   489-0071
MDR Report Key6957222
MDR Text Key89572731
Report Number3003775027-2017-00175
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK083127
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 10/18/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/17/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device Catalogue NumberCSW150-26N
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/12/2017
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: 10/17/2017 Patient Sequence Number: 1
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