FDA Adverse Event Injury Summary report: N

SENRI

MDR report key: 11606851 · Received April 2, 2021

Report

Report Number: 3002808904-2021-00005
Event Type: Injury
Date Received: April 2, 2021
Date of Event: August 31, 2020
Report Date: March 11, 2021
Manufacturer: KANEKA CORPORATION
Product Code: LIT
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

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.

Description of Event or Problem · 1

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
507547	SENRI	CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL, PRODUCT CODE: LIT	LIT	KANEKA CORPORATION		SP069126

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other