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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KANEKA CORPORATION PTA BALLOON CATHETER(OHICHO3) PTA BALLOON DILATATION CATHETER

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KANEKA CORPORATION PTA BALLOON CATHETER(OHICHO3) PTA BALLOON DILATATION CATHETER Back to Search Results
Catalog Number CH75-6040
Device Problems Material Puncture/Hole (1504); Device Handling Problem (3265)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/04/2017
Event Type  Injury  
Manufacturer Narrative
Results of investigations: the concerned device used was returned and investigated: the balloon was cross-sectionally sheared apart at about 33 mm from the distal tip of the device, however, the whole catheter shaft including the distal tip remained. Trace of rupture in the longitudinal direction was observed at the sheared apart point in both side of the separated balloon. In the visual inspection, no fragment of the device seemed to have lost, and the device was entirely recovered out of the patient. Results of a review of the device history records (dhr): the dhr (batch record) of the device concerned was reviewed: the production lot, to which this particular 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 balloon repetitive 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 device was used for a dialysis shunt pta. The balloon should have been injured by hardened and sharp edge of the lesion, and ruptured when the balloon was inflated. While retrieving it out of the patient, the bulky portion of the ruptured balloon was caught at the ostium of the sheath and became unable to pull back further out of the patient. No nonconformity or abnormality in the manufacturing processes of the device concerned was found, and accordingly, we determine that the reported event was caused by not any defect of the device but the user's handling issues.
 
Event Description
The concerned device subject to this reported event "ohicho 3", an otw-type pta balloon catheter compatible with 0. 035" guidewire (gw), is not approved in us, however, we intend to report this case as the event occurred on one of the similar devices for "metacross otw", an otw-type pta balloon catheter compatible with 0. 035" gw, which is distributed in us under 510(k) #152080. This device "ohicho 3" (hereafter "balloon catheter") was employed for a dialysis-shunt pta. The balloon ruptured at the third dilations in the lesion. The physician tried to retrieve the balloon catheter through the sheath device, however, the bulky part of the ruptured balloon could not enter into the sheath and became unable to pull back further. Then, the balloon catheter together with the sheath device were removed by a surgical operation.
 
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Brand NamePTA BALLOON CATHETER(OHICHO3)
Type of DevicePTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
KANEKA CORPORATION
2-3-18,nakanoshima,kita-ku
osaka-city,osaka 530-8288
JA
Manufacturer Contact
kazuhiko
2-3-18,nakanoshima,kita-ku
osaka, 530-8-288
3184120
MDR Report Key7145404
MDR Text Key95725278
Report Number3002808904-2017-00010
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 12/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2020
Device Catalogue NumberCH75-6040
Device Lot NumberSP117048
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/10/2017
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: 12/25/2017 Patient Sequence Number: 1
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