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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KANEKA CORPORATION PTA BALLOON CATHETER S4, JACKAL RX PTA BALLOON DILATATION CATHETER

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KANEKA CORPORATION PTA BALLOON CATHETER S4, JACKAL RX PTA BALLOON DILATATION CATHETER Back to Search Results
Catalog Number JKR 080 040 155
Device Problems Material Puncture/Hole (1504); Material Separation (1562); Device Handling Problem (3265)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/18/2017
Event Type  Injury  
Manufacturer Narrative
The concerned device "jackal rx" is a rapid-exchange (rx) type semi-compliant pta balloon dilatation catheter compatible to 0. 018" guidewire (gw). "jackal rx" 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. The actual device concerned was returned and investigated. The balloon was cut transversely at near the proximal shoulder of the balloon. The inner shaft was torn off at the welded portion with the distal tip. The length of the lost portion, from the distal tip to the balloon-breaking part was estimated to be about 50 mm. Two radiopaque markers fixed on the inner shaft remained. The outer shaft was deformed in multiple positions. The device history records (dhr) 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 balloon should have been injured by a sharp edge of the calcified lesion and was ruptured during being inflated. When the dr. Tried to retrieve the device out of the patient, the distal part of the ruptured balloon stuck at the orifice of the sheath device, and was broken apart by an excessive tensile strength. Then, further attempt to pull back the device torn off the inner shaft at the welded portion with the distal tip. 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
The lesion treated was an axillary vein with 75 to 90% stenosis, mildly calcified, and the vessel tortuosity was also mild. This balloon catheter was used for a balloon dilatation of the lesion. First, the balloon was inflated 4 times in the lesion at 12atm and for 30 seconds each. At the seventh dilatation, the inflation pressure could not elevate over 2 atm. Since a balloon rupture was suspected, the dr. Retrieved this balloon catheter out of the patient and found that a distal portion of the balloon was missing. The dr. Tried but could not locate the fragment of the balloon in the patient. Since the patient's condition was normal, the dr. Decided to leave it possibly remained in the patient and monitor the patient's condition.
 
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Brand NamePTA BALLOON CATHETER S4, JACKAL RX
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 Key7184788
MDR Text Key97054827
Report Number3002808904-2017-00014
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 12/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2020
Device Catalogue NumberJKR 080 040 155
Device Lot NumberSP087087
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/26/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/26/2017
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: 01/11/2018 Patient Sequence Number: 1
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