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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KANEKA CORPORATION SHIDEN HP CROSPERIO RX PTA BALLOON DILATATION CATHETER

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KANEKA CORPORATION SHIDEN HP CROSPERIO RX PTA BALLOON DILATATION CATHETER Back to Search Results
Catalog Number SD3-50040
Device Problems Material Separation (1562); Material Split, Cut or Torn (4008)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/24/2022
Event Type  Injury  
Event Description
Because of the terrible calcification of the lesion, this lesion was first dilated with "shiden hp 2. 0-40 mm". Next, the lesion was dilated with the concerned device ("shiden hp 5. 0-40 mm") to increase the size, and when the concerned device was removed, it was confirmed that there was no shaft from the distal tip to the gw port and that it remained in the vessel. The doctor attempted to retrieve the remaining broken fragment in the vessel using a snare, but was unable to do so. Since there was no vascular surgery department in the hospital, and the patient was transported to another hospital has the vascular surgery department. The broken fragment was removed from the patient.
 
Manufacturer Narrative
The concerned device "shiden hp" is a rapid-exchange (rx) type semi-compliant pta balloon dilatation catheter compatible to 0. 014" guidewire (gw). "shiden hp" 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. Please find below the results of our investigation: the device history records (dhr) of the concerned device was reviewed. The production lot, to which the concerned device 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 concerned device was found. No nonconformity or abnormality was found in the manufacturing processes according to the dhr. The concerned device used was not returned for our further investigation. Probable cause(s) and our comment: no nonconformity or abnormality in the manufacturing processes of the concerned device was found. It is inferred that this incident was caused by the terrible calcified lesion, and it is judged that there were no problems with the manufacturing or design of the device.
 
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Brand NameSHIDEN HP
Type of DeviceCROSPERIO RX PTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
KANEKA CORPORATION
2-3-18
nakanoshima, kita-ku
osaka, osaka 53082 88
JA 5308288
Manufacturer (Section G)
KANEKA CORPORATION OSAKA PLANT
5-1-1
torikai-nishi
settsu, osaka 56600 72
JA 5660072
Manufacturer Contact
joji sengoku
1-12-32 akasaka
minato-ku
tokyo 10760-28
JA   1076028
MDR Report Key14133507
MDR Text Key289422021
Report Number3002808904-2022-00007
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K152887
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 03/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberSD3-50040
Device Lot NumberSR060535
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/12/2020
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: 04/18/2022 Patient Sequence Number: 1
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