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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KANEKA CORPORATION KANEKA PTA CATHETER PE-R3, RX-GENITY PTA BALLOON DILATATION CATHETER

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KANEKA CORPORATION KANEKA PTA CATHETER PE-R3, RX-GENITY PTA BALLOON DILATATION CATHETER Back to Search Results
Catalog Number RXGT-30020
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 11/27/2017
Event Type  Injury  
Manufacturer Narrative
The concerned device "rx-genity" is a rapid-exchange (rx) type semi-compliant pta balloon dilatation catheter compatible to 0. 018" guidewire (gw). "rx-genity" 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, and so on. Since the concerned device used was not returned to the manufacturer, the dhr of the device with the lot no. Sp077289 was reviewed, and no nonconformity or abnormality in the manufacturing processes was found. The lot passed all in-process inspections including the balloon folded-shape check, the guidewire lumen integrity test and the shaft-pressurized test for every product, and the finished product inspections including the balloon-repetitive inflation/deflation test and the shaft tensile strength test on representative samples based on the sampling plan. The balloon portion of the rx-genity is protected with a balloon protective tube inserted over the balloon and a stylet inserted into the guidewire lumen, and the stylet and the balloon protective tube are instructed to be removed before use. It is obvious that the rx-genity was inserted into the patient's vessel with the balloon protective tube unremoved, hence the balloon could not be inflated, and the balloon protective tube came off while the catheter was pulled back and remained in the patient's vessel. We determined that the reported event was caused by not a defect or malfunction of the device but by a device handling issue.
 
Event Description
This pta balloon catheter was used for a pre-dilatation of the carotid artery stenosis. The device was delivered into the lesion and was attempted to dilate the lesion, but the balloon could not be expanded. Then, the device was once removed from the guiding catheter (gc) and inserted again. It was found that the balloon protection tube of the device had come off and remained in the patient's vessel. By a postoperative imaging, the location of the balloon protection tube in the vessel was confirmed. The physician tried but failed in retrieving it by using a snare device, and crimped it with a stent to complete the procedure.
 
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Brand NameKANEKA PTA CATHETER PE-R3, RX-GENITY
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 Key7124791
MDR Text Key95180047
Report Number3002808904-2017-00009
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 11/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2020
Device Catalogue NumberRXGT-30020
Device Lot NumberSP077289
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 Received11/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/10/2017
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: 12/18/2017 Patient Sequence Number: 1
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