FDA Adverse Event Injury Summary report: N

SENRI

MDR report key: 8770208 · Received July 9, 2019

Report

Report Number: 3002808904-2019-00016
Event Type: Injury
Date Received: July 9, 2019
Date of Event: March 25, 2019
Report Date: June 14, 2019
Manufacturer: KANEKA CORPORATION
Product Code: LIT
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE CONCERNED DEVICE "SENRI" IS A RAPID-EXCHANGE (RX) TYPE SEMI-COMPLIANT PTA BALLOON DILATATION CATHETER COMPATIBLE TO 0.018" GUIDEWIRE (GW). "SENRI" HAS NO APPROVAL IN THE US, HOWEVER, WE WILL REPORT THIS CASE AS AN INCIDENT OCCURRED ON A SIMILAR DEVICE FOR "CROSSTELLA RX" (A RX-TYPE PTA BALLOON DILATATION CATHETER, COMPATIBLE TO 0.018" GW) THAT IS DISTRIBUTED IN THE US UNDER 510(K) # K152873. SINCE THE USED WAS NOT RETURNED TO THE MANUFACTURER, WE WERE NOT ABLE TO ANALYZE IT. IN ADDITION, WE WERE NOT ABLE TO CHECK DHR BECAUSE THE BATCH NUMBER WAS UNIDENTIFIED. WE SPECULATE AS FOLLOWS, THE PROTECTIVE MATERIAL FOR THE BALLOON WAS LEFT ON THE BALLOON DURING PREPARATION OF THE BALLOON, AND INADVERTENTLY INSERTED INTO THE PATIENT. IN ADDITION, IFU HAS THE FOLLOWING NOTES: [OPERATION METHOD OR INSTRUCTIONS FOR USE]. PREPARATIONS: AFTER ASEPTICALLY REMOVING THIS CATHETER FROM THE PACKAGE CONTAINER, DETACH THE PROTECTIVE MATERIALS.

Description of Event or Problem · 1

ON 25/3, THIS "SENRI"PTA BALLOON CATHETER (HEREAFTER SAID "BALLOON CATHETER") WAS EMPLOYED FOR THE LOWER EXTREMITY ARTERY PTA. ON 31/5, BYPASS GRAFT SURGERY FOR RESTENOSIS WAS PERFORMED. THE PROTECTIVE MATERIAL FOR BALLOON CATHETER WAS FOUND AND REMOVED FROM THE POPLITEAL ARTERY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
567452	SENRI	CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL,	LIT	KANEKA CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention