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U.S. Department of Health and Human Services

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

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KANEKA CORPORATION SHIDEN PTA BALLOON DILATATION CATHETER Back to Search Results
Catalog Number SD-60020
Device Problems Material Fragmentation (1261); Material Separation (1562)
Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Event Date 12/06/2021
Event Type  Injury  
Event Description
Shiden (6. 0mm x 20mm) was inflated for the stenotic lesion with severe calcified, however the balloon was ruptured. Then the balloon was caught on the lesion, and the balloon was broken when it was pulled out. The broken fragment could not be pull out by the snare. The broken fragment was left in the patient and was tackled to the vessel wall with a stent.
 
Manufacturer Narrative
The concerned device subject to this reported event, "shiden", an rx-type pta balloon catheter compatible with 0. 014" guidewire (gw), is not distributed in the us, however, we intend to report this case as the event occurred on one of the similar devices for "crosperio rx pta balloon dilatation catheter" distributed in the us under 510(k) # k152887. Please find below the results of our investigation. 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 for every product, and the finished product inspections on representative samples based on sampling plan. No nonconformity or abnormality in the manufacturing processes of the device concerned was found. The concerned device was returned and investigated: we confirmed that a loss of about 5 mm at the distal tip and about 17 mm at the balloon. We confirmed that the balloon part was broken in the circumferential direction. We speculate the reported situation as follows: because it is used in calcified lesions, the rupture occurred because the balloon was damaged at the hard part of the lesion. Further, the operation was not possible at the lesioned part or the tip of the combined device (for example, gc), and when the catheter was removed from the stucked state, the balloon was broken by an excessive tensile force. This was considered a malfunction caused by the procedure. Neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.
 
Manufacturer Narrative
The concerned device subject to this reported event, "shiden", an rx-type pta balloon catheter compatible with 0. 014" guidewire (gw), is not distributed in the us, however, we intend to report this case as the event occurred on one of the similar devices for "crosperio rx pta balloon dilatation catheter" distributed in the us under 510(k) # k152887. Please find below the results of our investigation. 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 for every product, and the finished product inspections on representative samples based on sampling plan. No nonconformity or abnormality in the manufacturing processes of the device concerned was found. The concerned device was returned and investigated: we confirmed that a loss of about 5 mm at the distal tip and about 17 mm at the balloon. We confirmed that the balloon part was broken in the circumferential direction. We speculate the reported situation as follows: because it is used in calcified lesions, the rupture occurred because the balloon was damaged at the hard part of the lesion. Further, the operation was not possible at the lesioned part or the tip of the combined device (for example, gc), and when the catheter was removed from the "stucked" state, the balloon was broken by an excessive tensile force. This was considered a malfunction caused by the procedure. Neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.
 
Event Description
Shiden (6. 0mm x 20mm) was inflated for the stenotic lesion with severe calcified, however the balloon was ruptured. Then the balloon was caught on the lesion, and the balloon was broken when it was pulled out. The broken fragment could not be pull out by the snare. The broken fragment was left in the patient and was tackled to the vessel wall with a stent.
 
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Brand NameSHIDEN
Type of DevicePTA 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 Key13173711
MDR Text Key285923019
Report Number3002808904-2022-00001
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 12/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberSD-60020
Device Lot NumberSR100568
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/20/2020
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: 01/06/2022 Patient Sequence Number: 1
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