MAUDE Adverse Event Report: NUMED CANADA, INC. Z-MED II CATHETER PTV CATHETER

Model Number 305

Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/03/2018

Event Type  malfunction  

Manufacturer Narrative

The balloon burst was confirmed. Two comparative catheters from different lots were pulled and tested for rated burst pressure. The labeled rbp for this device is 5. 0 atm. The first comparative catheter was inflated until failure. The device was taken to rbp (5. 0 atms) with no issues. It was then over inflated to 11. 5 atms, which is greater than double the rbp, where it burst longitudinally. The second comparative catheter was also inflated until failure. The device was taken to rbp (5. 0 atms) with no issues. It was then over inflated to 11. 0 atms, which is also greater than double the rbp, where it burst longitudinally. It is unknown what caused the balloon to burst.

Event Description

"contract medium flowed out from the balloon when inflating the balloon. The inflation pressure was less than the rated burst pressure. ".

• Brand Name: Z-MED II CATHETER
• Type of Device: PTV CATHETER
• Manufacturer (Section D): NUMED CANADA, INC.; 45 second street west; cornwall, ontario K6J 1 G3; CA K6J 1G3
• Manufacturer (Section G): NUMED CANADA, INC.; 45 second street west; cornwall, ontario K6J 1 G3; CA K6J 1G3
• Manufacturer Contact: melissa thomas ; 2880 main street; hopkinton, NY 12965 ; 3153284491
• MDR Report Key: 8134599
• MDR Text Key: 129889890
• Report Number: 9618000-2018-00007
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K003052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/05/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 305
• Device Catalogue Number: PDZ657
• Device Lot Number: JZ-19172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown