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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KANEKA CORPORATION PTA CATHETER H4, DIVA PTA BALLOON DILATATION CATHETER

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KANEKA CORPORATION PTA CATHETER H4, DIVA PTA BALLOON DILATATION CATHETER Back to Search Results
Catalog Number DV15-04100RC
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/13/2017
Event Type  Injury  
Manufacturer Narrative
The concerned device "diva" is a rapid-exchange (rx) type semi-compliant pta balloon dilatation catheter compatible to 0. 018" guidewire (gw). "diva" has no approval in the us, however, we will report this case as an incident occurred on a similar device for "crosstella rx", a rx-type pta balloon dilatation catheter, compatible to 0. 018" gw, that is distributed in the us under 510(k) # k152873. Since the actual device concerned was not returned, the device history records (dhr - batch records) of the device concerned was reviewed: the production lot, to which the 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 repetitive balloon 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 gw port of this device seemed to have located outside the tip of the sheath during operation. While the device was being pulled back to remove out of the patient, the gw made a loop and kinked at the orifice of the sheath and the gw port of the device became unable to come back in the sheath. It seemed that the sheath device used was too short to reach the vicinity of the lesion to treat and the gw port of this device became outside the sheath to treat the lesion. Accordingly, as described above, the portion of the gw outside the sheath and the gw port became kinked and made the gw port of this device impossible to come back into the sheath. No nonconformity or abnormality in the manufacturing processes of the device concerned was found, and accordingly, we determine that the event reported was caused by not any defect of the device but the user's handling issues.
 
Event Description
This device "diva", a pta balloon dilatation catheter (balloon size: 4mm x 100mm), was used for a balloon-dilatation of the lesion in the right sfa. Approached from the right brachial artery, this device was delivered to the lesion along a gw. The balloon-dilatation of the lesion was successfully done and the balloon was deflated without problem. While retrieving the device out of the patient, it became stuck and difficult to move. It was found via a fluoroscopy that the gw made a loop and kinked near the puncture site. Since the distal tip of the device already came back to the vicinity of the subclavian artery, the dr. Tried to pull back the device further to remove, however, the patient alleged pain in the brachial and gave up to pulling out the device. Then, the dr. Inserted a microcatheter over the device to draw in the device together with the gw, but it was failed. Finally, the dr. Decided to transfer the patient to another facility to remove the devices out of the patient by a surgical operation.
 
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Brand NamePTA CATHETER H4, DIVA
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 Key7145405
MDR Text Key95727630
Report Number3002808904-2017-00013
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 12/13/2017
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 Date10/31/2019
Device Catalogue NumberDV15-04100RC
Device Lot NumberSP116296
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/08/2016
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: 12/25/2017 Patient Sequence Number: 1
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