• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KANEKA CORPORATION PTA BALLOON CATHETER(OHICHO3) PTA BALLOON DDILATATION CATHETER, PRODUCT CODE: LIT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

KANEKA CORPORATION PTA BALLOON CATHETER(OHICHO3) PTA BALLOON DDILATATION CATHETER, PRODUCT CODE: LIT Back to Search Results
Catalog Number CH45-6040
Device Problems Break (1069); Device Handling Problem (3265)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 11/16/2017
Event Type  Injury  
Manufacturer Narrative
Results of a review of the device history records (dhr): the dhr of the concerned device were checked by the reported lot number and the serial number: it was confirmed that the device passed all the in-process and the finished product inspections, e. G. , the pressure tightness test, the balloon folding inspection, the appearance inspection, which are carried out in every product, and the balloon inflation test, the tensile strength test, conducted by representative sample. Probable cause(s): the balloon should have been injured by contacting with lesions, and ruptured when the balloon was inflated. While retrieving it out of the patient, the bulky part of the balloon due to the rupture was caught at the ostium of the sheath and became unable to pull back further out of the patient. Our comments: since no abnormalities or problems was found in the device history records (dhr), we determine that the reported problem 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 distributed 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 "ohicho 3" pta balloon catheter (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 patient was transferred to another facility and the balloon catheter together with the sheath device were removed by a surgical operation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePTA BALLOON CATHETER(OHICHO3)
Type of DevicePTA BALLOON DDILATATION CATHETER, PRODUCT CODE: LIT
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 Key7111854
MDR Text Key94631794
Report Number3002808904-2017-00007
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 11/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2020
Device Catalogue NumberCH45-6040
Device Lot NumberSP067286
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 Received11/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 12/13/2017 Patient Sequence Number: 1
-
-