FDA Adverse Event Injury Summary report: N

SUPER SHEATH

MDR report key: 7202934 · Received January 18, 2018

Report

Report Number: 9612126-2018-00001
Event Type: Injury
Date Received: January 18, 2018
Date of Event: December 17, 2017
Report Date: January 18, 2018
Manufacturer: TOGO MEDIKIT CO.LTD.
Product Code: DRE
PMA / PMN Number: K141070
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE INVOLVED IN THE EVENT WAS RETURNED. THE RETURNED DEVICE WAS EXAMINED, AND THE REPEATABILITY TEST WAS CONDUCTED USING RESERVED SAMPLES. ALSO, THE INVESTIGATION WAS CONDUCTED BY REVIEWING THE RECORDS OF THE MANUFACTURING PROCESSES OF THE SHEATH, AND IT WAS CONFIRMED THAT THERE WERE NO MANUFACTURING PROCESSES THAT CAUSED OR CONTRIBUTED TO THE EVENT. JUDGING FROM THIS EXAMINATION, A POSSIBLE CAUSE OF THIS FRACTURE COULD BE THAT A SHARP EDGE SUCH AS A KNIFE CAME INTO CONTACT WITH THE SHEATH DURING THE PROCEDURE. THIS RESULTED IN A DECREASE IN TENSILE STRENGTH OF THE SHEATH TO A POINT WHERE THE SHEATH COULD NOT WITHSTAND THE PULL FORCE AND FRACTURED. THE MEDICAL DEVICE INVOLVED IN THE REPORTED EVENT IS SOLD ONLY IN (B)(4). THEREFORE, THE INFORMATION ON THE EQUIVALENT DEVICE TO THE COMPLAINT DEVICE THAT WAS CLEARED UNDER K141070.

Description of Event or Problem · 1

ON (B)(6) 2017, AT A HOSPITAL IN (B)(6), IT WAS REPORTED THAT THE SUPER SHEATH WAS FRACTURED WHEN IT WAS PULLED OUT OF A PATIENT'S BODY DURING A PROCEDURE. THE FRACTURED PORTION REMAINED IN THE PATIENT'S BODY AND WAS REMOVED ADEQUATELY. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
47879	SUPER SHEATH	DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION	DRE	TOGO MEDIKIT CO.LTD.		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR		Required Intervention