FDA Adverse Event Malfunction Summary report: N

EKOSONIC ENDOVASCULAR CATHETER

MDR report key: 7492335 · Received May 7, 2018

Report

Report Number: 3001627457-2018-00015
Event Type: Malfunction
Date Received: May 7, 2018
Date of Event: April 12, 2018
Report Date: April 12, 2018
Manufacturer: EKOS CORPORATION
Product Code: KRA
UDI-DI: 00858593006189
PMA / PMN Number: K140151
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE EKOSONIC MSD WAS RETURNED IN TWO PIECES WITH THE IDDC. THE DEVICE EVALUATION REVEALED PINCH MARKS THROUGHOUT THE MSD TUBING; THE MSD FRACTURE WAS NOTED AT THE PROXIMAL END OF GROUP 5 AND THE SHAFT TO TREATMENT ZONE JUNCTION. VISUAL INSPECTION OF THE IDDC NOTED A KINK IN THE TUBING AND THE STIFFENING WIRE AT 9.4 CM. THE IFU WARNS THE USER IF THE PRODUCT IS DAMAGED OR FOUND TO BE UNUSABLE IN ANY WAY, PLEASE RETAIN THE PRODUCT AND NOTIFY EKOS CORPORATION IMMEDIATELY. USER ERROR WAS NOT CONFIRMED, BUT COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTING FACTOR TO THE MSD FRACTURE.

Description of Event or Problem · 1

IT WAS REPORTED THAT A 50 CM EKOS CATHETER WAS USED TO TREAT A PATIENT WITH A UNILATERAL ARTERIAL OCCLUSION ON (B)(6) 2018. THE CATHETER RAN ONE HOUR AND 39 MINUTES. WHEN IT WAS PULLED OUT, IT WAS DISCOVERED THE MSD WAS FRACTURED INSIDE THE IDDC. THE 50CM CATHETER WAS REPLACED WITH A 30CM THAT RAN FOR 20 HOURS AND IT WAS REPORTED THAT THE PATIENT DID FINE. THE PATIENT WAS NOT HARMED AS A RESULT OF THE FRACTURED MSD. UPON INVESTIGATION OF THE RETURNED DEVICE, THE REPORTED COMPLAINT WAS CONFIRMED BY DEVICE DAMAGE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
335059	EKOSONIC ENDOVASCULAR CATHETER	CATHETER	KRA	EKOS CORPORATION	500-55150		00858593006189

Patients

Seq	Age	Sex	Outcome	Treatment
1