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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KANEKA CORPORATION R2P METACROSS RX CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL, PRODUCT CODE: LIT

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KANEKA CORPORATION R2P METACROSS RX CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL, PRODUCT CODE: LIT Back to Search Results
Model Number BD-P80040ER
Device Problems Material Rupture (1546); Material Separation (1562); Use of Device Problem (1670); Device Handling Problem (3265)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/02/2020
Event Type  Injury  
Manufacturer Narrative
From the investigation of the actual product, we confirmed a loss of about 42 mm in total for the rupture of the balloon part and the balloon part and the tip part. On the other hand, we have confirmed that there is no problem with the device history record. Our balloon part is designed to rupture in the vertical direction regarding pressure from the inside, but it may rupture in the lateral direction when expanding in calcified lesions or tortuous lesions etc. The actual device was broken by pulling it in a state when the balloon portion was ruptured in the lateral direction. This was considered a malfunction caused by the procedure.
 
Event Description
During a fistulogram angioplasty, you could see the balloon not fully expand even at burst pressure. The balloon burst. Upon removal it was noted that the balloon burst circumferentially vs longitudinally and part of the balloon (nylon) was left in the aneurysmal section of the fistula. The balloon catheter was removed and the patient access site closed.
 
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Brand NameR2P METACROSS RX
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL, PRODUCT CODE: LIT
Manufacturer (Section D)
KANEKA CORPORATION
2-3-18
nakanoshima, kita-ku
osaka-city, osaka 530-8 288
JA 530-8288
Manufacturer (Section G)
KANEKA CORPORATION OSAKA PLANT
5-1-1
torikai-nishi
settsu-city, osaka 56600 72
JA 5660072
Manufacturer Contact
joji sengoku
1-12-32
akasaka
minato-ku, tokyo 10700-52
JA   1070052
MDR Report Key10753317
MDR Text Key213670636
Report Number3002808904-2020-00020
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K163479
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 10/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberBD-P80040ER
Device Catalogue NumberBD-P80040ER
Device Lot NumberSR040143
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/26/2020
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: 10/29/2020 Patient Sequence Number: 1
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