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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KANEKA CORPORATION SHIDEN CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL, PRODUCT CODE: LIT

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KANEKA CORPORATION SHIDEN CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL, PRODUCT CODE: LIT Back to Search Results
Catalog Number SD-60040
Device Problems Material Separation (1562); Use of Device Problem (1670); Device Handling Problem (3265)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 06/24/2020
Event Type  Injury  
Manufacturer Narrative
The concerned device "shiden" is a rapid-exchange (rx) type semi-compliant pta balloon dilatation catheter compatible to 0. 014" guidewire (gw). "shiden" has no approval in the us, however, we will report this case as an incident occurred on a similar device for "crosperio rx" (a rx-type pta balloon dilatation catheter, compatible to 0. 014" gw) that is distributed in the us under 510(k) # k152887. Since the actual device was not retuned, we investigated the device history records. The device history records (dhr) of the device concerned was reviewed: the production lot, to which the device concerned belongs, passed all in-process inspections including the visual test, shaft pressurized test and the balloon-wrapping test for every product, and the finished product inspections including the shaft tensile strength test and the repetitive balloon inflation/deflation test on representative samples based on sampling plan. No nonconformity or abnormality in the manufacturing processes of the device concerned was found. No nonconformity or abnormality was found in the manufacturing processes according to the dhr. We believe the reported problem would not be caused by any defect of the device.
 
Event Description
Since sfa ruptured during the evt of the patient who had the stent graft in the terminal aorta, the doctor approached with gc 55cm 7fr from brachial and placed "viabahn 7mm-50mm". Then, with "shiden 6mm-40mm", 5 minutes x 5 to 6 expansions were performed at 10 atm to stop the bleeding. After that, when he tried to pull back shiden, he felt a strong resistance, so he was pulling out gc, gw and shiden together, but the shaft broken and the balloon part remained in the body as it was.
 
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Brand NameSHIDEN
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL, PRODUCT CODE: LIT
Manufacturer (Section D)
KANEKA CORPORATION
2-3-18
nakanoshima, kita-ku
osaka-city, osaka 530-8 288
JA 530-8288
Manufacturer Contact
joji sengoku
1-12-32
akasaka
minato-ku, tokyo 10700-52
JA   1070052
MDR Report Key10256477
MDR Text Key198320103
Report Number3002808904-2020-00014
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 06/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberSD-60040
Device Lot NumberSR040434
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 Received06/25/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/26/2020
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: 07/10/2020 Patient Sequence Number: 1
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