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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KANEKA CORPORATION R2P CROSSTELLA RX CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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KANEKA CORPORATION R2P CROSSTELLA RX CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number BD-Q20100ER
Device Problems Material Separation (1562); Use of Device Problem (1670); Device Handling Problem (3265)
Patient Problem Foreign Body In Patient (2687)
Event Date 04/30/2020
Event Type  Injury  
Manufacturer Narrative
Since the actual device was not retuned, we investigated the device history records. 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 visual test, 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. No nonconformity or abnormality was found in the manufacturing processes according to the dhr. We believe the reported problem would not be caused by any defect of the device. Factors that may contribute to the balloon stuck include, but are not limited to the following. Balloon wrapping after deflation may be distorted depending on the number of balloon dilations, themeandering lesion state etc. As a result, removal resistance to the sheath (gc) may increase. Also, if the deflation is insufficient, the balloon will be caught on the tip of the sheath or gc, and the balloon will not be able to be retracted into the sheath or the gc. The balloons were stuck due to such causes, and in that state, the balloons were pulled due to strong pulling and were broken. In addition, ifu has the following notes: [precautions during usage] 16. If any abnormality such as strong resistance is experienced while manipulating the catheter, the procedure should be discontinued immediately. The cause should be verified and appropriate measures should be taken. (continuing the operation with excessive force may result in damage to the catheter or in vascular wall injury. ) 21. While inserting this device into the blood vessel or removing this device from the blood vessel, make sure that the balloon is completely deflated. ( a device with larger and longer balloon requires a longer deflation time. ) 22. If resistance is felt during post procedural withdrawal of this device, it is recommended to withdraw the entire system together with the introducer / guide sheath.
 
Event Description
A cardiologist was performing a peripheral intervention using the r2p crosstella to balloon in the tibial vessel via femoral access. He had inflated the balloon in the tibial vessel and then deflated it without difficulty. Upon retraction of the balloon the md noticed resistant in the proximal sfa area where the balloon was stuck. As he pulled harder to try and remove the balloon, the balloon broke off from the shaft of the balloon remaining inside the patient while the shaft was removed. Multiple attempts to snare was unsuccessful so the md chose the crush the balloon against the vessel wall with a stent.
 
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Brand NameR2P CROSSTELLA RX
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
KANEKA CORPORATION
2-3-18
nakanoshima,kita-ku
osaka-city, osaka 530-8 288
JA 530-8288
Manufacturer Contact
tamiji fujimoto
2-3-18
nakanoshima,kita-ku
osaka-city, osaka 530-8-288
JA   530-8288
MDR Report Key10064346
MDR Text Key196939571
Report Number3002808904-2020-00008
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152873
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial
Report Date 04/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberBD-Q20100ER
Device Lot NumberSP129249
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 Received05/01/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/04/2019
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: 05/18/2020 Patient Sequence Number: 1
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