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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KANEKA CORPORATION CROSPERIO RX CROSPERIO RX PTA BALLOON DILATATION CATHETER

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KANEKA CORPORATION CROSPERIO RX CROSPERIO RX PTA BALLOON DILATATION CATHETER Back to Search Results
Catalog Number BD-B30080LR
Device Problems Material Separation (1562); Use of Device Problem (1670); Device Handling Problem (3265)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 11/07/2017
Event Type  Injury  
Manufacturer Narrative
The actual device concerned was not returned. 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 injured on the delivery through the lesion and was ruptured while being inflated in the lesion. When the dr. Tried to retrieve the device, the bulky distal portion of the ruptured balloon was trapped in the lesion. Further attempts to pull back the device resulted in the fracture of the balloon and the device came out of the patient's vessels with the fractured balloon portion remained in the lesion. 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 case was a pta on the lower extremity. The guidewire passed the lesion and the dr. Decided on pre-dilatation prior to stent placement. A 0. 014 inch balloon catheter, the device concerned, was used. The balloon burst prior to complete inflation. The balloon catheter was removed but it was observed that some part of the balloon was missing. The fractured balloon portion was found at the lesion, and the dr. Tried but failed to remove it out of the lesion. A stent was advanced over area and deployed over the balloon fragment. A 0. 035 inch balloon catheter was used for post stent dilatation, and the exam completed.
 
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Brand NameCROSPERIO RX
Type of DeviceCROSPERIO RX PTA 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 Key7081851
MDR Text Key93683224
Report Number3002808904-2017-00008
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152887
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 11/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2019
Device Catalogue NumberBD-B30080LR
Device Lot NumberSP036144
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 Received11/10/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/12/2016
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: 12/04/2017 Patient Sequence Number: 1
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