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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KANEKA CORPORATION SENRI CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL, PRODUCT CODE: LIT

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KANEKA CORPORATION SENRI CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL, PRODUCT CODE: LIT Back to Search Results
Catalog Number BD-J3020L
Device Problems Use of Device Problem (1670); Device Handling Problem (3265)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/31/2020
Event Type  Injury  
Manufacturer Narrative
The concerned device subject to this reported event, "senri", an rx-type pta balloon catheter compatible with 0. 018" guidewire (gw), is not distributed in the us, however, we intend to report this case as the event occurred on one of the similar devices for "crosstella rx pta balloon dilatation catheter" distributed in the us under 510(k) # k152873. The device history records (dhr) of the device concerned was reviewed: no nonconformity or abnormality in the manufacturing processes of the device concerned was found. Results of the investigation on returned concerned device: no nonconformity or abnormality in the concerned device was found. Conclusion: it was speculated that the operation was caused by forgetting to remove the balloon protection tube and inserting it into the blood vessel.
 
Event Description
The product was used for pta for shunt stenosis. At that time, the procedure was completed without any problems, but due to repeated stenosis, a balloon protection tube was confirmed inside the body when confirmed by angio, echo, etc. The blood vessels were surgically opened and the protection tube was removed from the body.
 
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Brand NameSENRI
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
settsu-city
osaka, 56600 72
JA 5660072
Manufacturer Contact
joji sengoku
1-12-32
akasaka
minato-ku, tokyo 10700-52
JA   1070052
MDR Report Key11606851
MDR Text Key243946863
Report Number3002808904-2021-00005
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 03/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2022
Device Catalogue NumberBD-J3020L
Device Lot NumberSP069126
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2019
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: 04/02/2021 Patient Sequence Number: 1
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