MAUDE Adverse Event Report: NUMED CANADA, INC. Z-5 ATRIOSEPTTOSTOMY CATHETER

Model Number 210

Device Problems Break (1069); Material Fragmentation (1261); Inflation Problem (1310); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Event Description

Per the physician: there was an aneurysmal septum, and it is possible that the balloon somehow caught in it.The first septostomy was done with another balloon.Since that balloon could not be re-inflated for a second pull, it was removed from the body uneventfully and this balloon was inserted.The balloon crossed the atrial septum easily, was inflated and pulled against the la side of the septum, but did not cross to the right atrium with several pulls.When we tried to forcefully pull the balloon through the septum, it broke off from the catheter.The baby was taken to the cath lab to attempt retrieval, since the balloon embolized to the aorta (in consultation with a surgeon).In the lab we were able to snare the balloon on both sides (using gooseneck snares) but as it was partly inflated, we could not retrieve it into a long sheath, and the baby required operative retrieval.

Manufacturer Narrative

This complaint catheter as well as (4) other catheters from the same lot were returned by the hospital.These (4) catheters were tested for pull strength using a calibrated instron machine and exhibited pull break forces that ranged from 11.61 ibf to 13.58 ibf.It was stated that this case had an anatomical problem that may have contributed to this issue.All of these catheters exhibited a pull force in excess of both minimum value (3 ibf.) and the test values (7-9 ibf.) that were reported in the design dossier testing.It is further noted that a maximum pull force of approximately 6 ibf.Was the maximum that could be generated by hand without wrapping the catheter shaft around ones hand to pull.An excessive force would have to have been applied to break this catheter.There is a statement in the instructions for use that excessive force to pull the balloon across the atrial septum must be avoided.Specifically, the physician should avoid using the entire arm when pulling the balloon across the septum and should instead use only the motion of the wrist.It also give instructions on what to do if the balloon does not easily cross the septum using this method.

• Brand Name: Z-5 ATRIOSEPTTOSTOMY CATHETER
• Manufacturer (Section D): NUMED CANADA, INC.; 45 second st. west; cornwall, ontario K6J 1 G3; CA K6J 1G3
• Manufacturer (Section G): NUMED CANADA, INC.; 45 second st. west; cornwall, ontario K6J 1G3; CA K6J 1G3
• Manufacturer Contact: nichelle laflesh ; 2880 main street; hopkinton, NY 12965 ; 3153284491
• MDR Report Key: 3834647
• MDR Text Key: 4393787
• Report Number: 9618000-2014-00001
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K960070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 04/30/2018
• Device Model Number: 210
• Device Catalogue Number: SPT003
• Device Lot Number: AS-1421
• Date Returned to Manufacturer: 01/15/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 DA