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U.S. Department of Health and Human Services

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

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KANEKA CORPORATION PTA BALLOON CATHETER (OHICHO III) PTA BALLOON DILATATION CATHETER Back to Search Results
Catalog Number CH45-5040
Device Problems Material Separation (1562); Material Integrity Problem (2978); Device Handling Problem (3265)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/01/2017
Event Type  Injury  
Manufacturer Narrative
Results of investigations: the concerned device (balloon catheter) used was returned and investigated. The balloon was sheared apart at about 25 mm from the tip of the balloon catheter, and the inner shaft (the guidewire lumen) was significantly elongated but not sheared off. There was a longitudinal crack at the fracture portion on the proximal side of the separated balloon. Survey result of device history records (dhr): the device history records (dhr) of the concerned device were checked by the lot number and the serial number of the actual device returned. 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 products, and the balloon inflation test, the tensile strength test, conducted by representative sample. Estimated cause(s): the balloon should have been injured by contacting with severely hardened lesions of the anastomosis portion and the like, and ruptured longitudinally 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 was not able to enter without being drawn into the sheath. Then, the balloon cracked vertically to the axis of the catheter due to the excessive force loaded when the physician tried further to pull it back, and the balloon was sheared apart, and became unable to remove it out of the patient. Our comments: since no abnormalities or problems was found in the device history records (dhr), the balloon of the concerned device should be sheared apart due to excessive force loaded when the physician tried forcibly to pull out of the patient while the ruptured balloon portion was caught at the ostium of the sheath. Accordingly, 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 iii", an otw-type pta balloon catheter compatible with 0. 035" guidewire, 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" guidewire, which is distributed in us under 510(k) #k152080. This "ohicho iii" pta balloon catheter (hereafter said "balloon catheter") was employed for a dialysis-shunt pta. The balloon of the pta balloon catheter ruptured in the 14th dilations at an inflating pressure of 18 atm at the anastomosis site, after 3 times of dilations at 22 atm (the rated burst pressure (rbp) of this balloon catheter). Then, the physician tried to retrieve the balloon catheter through the sheath device, however, the ruptured balloon-part could not enter the sheath, and it became impossible to remove out of the patient. The patient was transferred to an another facility, and the balloon catheter and the sheath device were removed by a surgical operation.
 
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Brand NamePTA BALLOON CATHETER (OHICHO III)
Type of DevicePTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
KANEKA CORPORATION
2-3-18 nakanoshima, kita-ku
osaka-city, osaka 530-8 288
JA 530-8288
Manufacturer Contact
kazuhiko inoue
2-3-18 nakanoshima, kita-ku
osaka-city, osaka 530-8-288
JA   530-8288
31814120
MDR Report Key6438363
MDR Text Key70971952
Report Number9614654-2017-00003
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 03/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2019
Device Catalogue NumberCH45-5040
Device Lot NumberSP017015
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/03/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/27/2016
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: 03/28/2017 Patient Sequence Number: 1
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