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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KANEKA CORPORATION SHIRANUI EX

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KANEKA CORPORATION SHIRANUI EX Back to Search Results
Catalog Number SE45-6040
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 04/24/2021
Event Type  Injury  
Manufacturer Narrative
The actual device was returned. It was confirmed that the balloon was broken. 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 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. Probable cause(s) and our comment: the balloon may have damaged by the calcified lesion of shunt pta and should have been ruptured when the balloon was inflated. While removing it from the patient, the bulky portion of the ruptured balloon was caught on the sheath and could not be pulled back any more. Further attempts to forcibly pull back the device resulted in breakage of the balloon and the tip, and the broken pieces remained in the patient's blood vessel.
 
Event Description
Shiranui ex is an over the wire type semi-compliant pta balloon catheter compatible with 0. 018 inch guidewire. Shiranui ex has no approval in usa. However, we intend to report this case as the event occurred on the similar device for " crosstella otw" (otw type pta balloon dilatation catheter,0. 018" guidewire compatible) in us under 510(k)# k160004. ".
 
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Brand NameSHIRANUI EX
Type of DeviceSHIRANUI EX
Manufacturer (Section D)
KANEKA CORPORATION
2-3-18
osaka, 530-8 288,
JA 530-8288,
Manufacturer Contact
joji
akasaka
minato-ku
tokyo, 107-6-028
MDR Report Key11869225
MDR Text Key252156760
Report Number3002808904-2021-00006
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 04/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSE45-6040
Device Lot NumberSP120463
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/14/2020
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: 05/24/2021 Patient Sequence Number: 1
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