FDA Adverse Event Malfunction Summary report: N

X-FLOW CATHETER

MDR report key: 10108420 · Received June 2, 2020

Report

Report Number: 9610711-2020-00017
Event Type: Malfunction
Date Received: June 2, 2020
Report Date: June 10, 2020
Manufacturer: COLOPLAST A/S
Product Code: EZL
UDI-DI: 03600040144442
PMA / PMN Number: K013172
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

WE RECEIVED A SAMPLE BLOODED WITH A LOT NUMBER ON THE VALVE 6957578. THE BALLOON IS BURST BUT ENTIRE. THE AB632280 LOT 6957578 WAS THE INTERMEDIATE PRODUCT OF THE AB63221002 LOT 7081372 THE AB63221002 LOT 7081372 HAS BEEN PACKAGED IN SEPT 2019 FOR 1060 PIECES AND THE EXPIRY DATE IS SEPT 2024 AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINT AND WE DIDN'T FIND OTHER COMPLAINT ON THE LOT NUMBER 7081372 FROM EXPERIENCE, SILICONE BALLOON BURSTING COULD COME FROM VARIOUS CAUSES. IN THIS CASES WE CAN NOT IDENTIFY ANY SPECIFIC ROOT CAUSE AS UNSUFFICIENT INFORMATION HAS BEEN PROVIDED TO DO SO. THE SILICONE BALLOON ISSUE IS KNOWN AND FOLLOWED IN PARALLEL, A SPECIFIC TREND IS MONITORED REGARDING THE SILICONE BALLOON ISSUE.

Additional Manufacturer Narrative · 1

WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. ONCE OUR EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

ACCORDING TO THE AVAILABLE INFORMATION, ONCE THE DEVICE WAS INTRODUCED INTO THE PATIENT, A RUPTURE OF THE BALLOON OCCURRED DURING INFLATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
573040	X-FLOW CATHETER	PROSTATECTOMY CATHETER	EZL	COLOPLAST A/S	AB63221002	7081372	03600040144442

Patients

Seq	Age	Sex	Outcome	Treatment
1