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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 CH45-5040
Device Problems Material Rupture (1546); Material Separation (1562); Use of Device Problem (1670); Device Handling Problem (3265)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 04/05/2018
Event Type  Injury  
Manufacturer Narrative
Results of investigations: the concerned device used was returned and investigated: the device returned consisted of the distal tip with the broken balloon fragment and the catheter shaft from the distal torn off portion through the intact manifold (the proximal end) of the device. The balloon was broken at 3 cm from the distal tip. The inner-shaft (the guidewire lumen) was elongated and torn off at the welded portion with the distal tip. The distal radiopaque marker was dislodged from the torn off inner-shaft and was missing, which was suspected to remain in the patient's vessel. 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 balloon should have been injured by hardened and sharp edge of the lesion, and was 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 stuck there. Further attempts to pull back the device forcibly resulted in torn off of the balloon and the inner-shaft to remain the broken fragment in the patient's vessel. 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. The balloon ruptured after several dilations in the lesion. The physician tried to retrieve the balloon catheter, however, the bulky part of the ruptured balloon could not enter into the sheath device and a strong resistance to pull back further was encountered. A further attempt to forcibly pull back the balloon catheter resulted in torn apart of the balloon portion and a broken fragment remained in the patient's blood vessel. The physician tried but could not locate the fragment in the patient's vessel, and completed the procedure with it remained in the patient.
 
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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
yoshiyuki kitamura
2-3-18, nakanoshima, kita-ku
osaka, 530-8-288
JA   530-8288
2265138
MDR Report Key7467415
MDR Text Key106695830
Report Number3002808904-2018-00007
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,u
Reporter Occupation
Type of Report Initial
Report Date 04/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2020
Device Catalogue NumberCH45-5040
Device Lot NumberSP018414
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/06/2018
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: 04/26/2018 Patient Sequence Number: 1
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