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

Model Number 210

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504); Device Dislodged or Dislocated (2923)

Patient Problems Death (1802); Disseminated Intravascular Coagulation (DIC) (1813); Embolism (1829)

Event Date 06/13/2019

Event Type  Death  

Manufacturer Narrative

The device has not been received for evaluation at this time.Device history records were reviewed and no issues were found.Data from the physician was reviewed and it was determined that the wrong guidewire size was used with this device.If the appropriate guidewire had been used, it would have been less likely for the balloon to have traveled after separation.Also from the report it seems that a traumatic injury happened during the snaring of the balloon.The physician stated that an ultrasound of the abdomen showed fluid collection in the retroperitoneal area which raised suspicion of vascular retroperitoneal bleeding.An angiogram was performed and confirmed a pin hole leak in to retroperitoneal area from the right common iliac artery.It was repaired and the patient was transferred to pcicu.While in pcicu the patient developed dic picture.This mdr will be updated once more information becomes available.

Event Description

As per the initial notification via email from the foreign distributor: "balloon atrial septostomy case and unfortunately the balloon has dislodged from the catheter and they retrieve it by snare catheter and patient have sent for the surgery." additional information that was received on 06/17/2019 from the foreign distributor: "balloon disconnected from the catheter and embolized to the descending aorta." "traumatic injury to right common iliac artery (during snaring of the balloon).Patient was transferred to or and procedure performed, identified the pin hole leak and repaired the was transferred to pcicu.While in pcicu; patient developed dic picture.".

Manufacturer Narrative

The device has not been received for evaluation at this time.Device history records were reviewed and no issues were found.Data from the physician was reviewed and it was determined that the wrong guidewire size was used with this device.If the appropriate guidewire had been used, it would have been less likely for the balloon to have traveled after separation.Also from the report it seems that a traumatic injury happened during the snaring of the balloon.The physician stated that an ultrasound of the abdomen showed fluid collection in the retroperitoneal area which raised suspicion of vascular retroperitoneal bleeding.An angiogram was performed and confirmed a pin hole leak in to retroperitoneal area from the right common iliac artery.It was repaired and the patient was transferred to pcicu.While in pcicu the patient developed dic picture.This mdr will be updated once more information becomes available.

Event Description

As per the initial notification via email from the foreign distributor: "balloon atrial septostomy case and unfortunately the balloon has dislodged from the catheter and they retrieve it by snare catheter and patient have sent for the surgery." additional information that was received on 06/17/2019 from the foreign distributor: "balloon disconnected from the catheter and embolized to the descending aorta." "traumatic injury to right common iliac artery (during snaring of the balloon).Patient was transferred to operating room and procedure performed, identified the pin hole leak and repaired the was transferred to pcicu.While in pcicu; patient developed dic picture.".

Manufacturer Narrative

The device has not been received for evaluation at this time.Device history records were reviewed and no issues were found.Data from the physician was reviewed and it was determined that the wrong guidewire size was used with this device.If the appropriate guidewire had been used, it would have been less likely for the balloon to have traveled after separation.Also from the report it seems that a traumatic injury happened during the snaring of the balloon.The physician stated that an ultrasound of the abdomen showed fluid collection in the retroperitoneal area which raised suspicion of vascular retroperitoneal bleeding.An angiogram was performed and confirmed a pin hole leak in to retroperitoneal area from the right common iliac artery.It was repaired and the patient was transferred to pcicu.While in pcicu the patient developed dic picture.This mdr will be updated once more information becomes available.Update: the complaint catheter was received and the balloon detachment confirmed.The catheter returned in two separate sections first piece was the balloon and portion of the catheter shaft.The second piece was the catheter shaft and proximal attachments.The balloon and shaft were bloody.There was contrast in the balloon.The detachment occurred 1 mm behind the proximal balloon bond.The shaft was stretched where the detachment occurred.The pediatric cardiac procedure note states under procedure; "a 4 french jr 3.0 catheter was used to put a 0.014 x190 bmx across atrial septum." (the labeled rated guidewire size for this catheter is a 0.021" guidewire.) a comparative catheter was pulled and tested.The comparative catheter was from the same lot as the complaint device (as-2155).The comparative catheter was loaded into the special test fixture (instron) and pull tested in a manner similar to that which was used for the original bench testing of this catheter model for the regulatory submissions.The shaft failed with a pull force of 10.15 lbf., which is equal to 45.15 newtons.This value exceeds the acceptance criteria (8.9 newtons) that was used for the original bench testing as well as the actual results of the bench testing (range 31.1-40.0 newtons, average 35.6 newtons, std.Dev.4.448) the comparative catheter broke in the same area.The break was similar in appearance to the complaint catheter.The device was being used with the incorrect guidewire size.The instructions for use manual that is sent with every device has the following statements: "the use of 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.If the balloon does not easily cross the septum using this method, it is recommended that a smaller volume of fluid be used initially." this method was also confirmed by the consultant physician as being the choice that should have been used based on the initial pfo size.

Event Description

As per the initial notification via email from the foreign distributor: "balloon atrial septostomy case and unfortunately the balloon has dislodged from the catheter and they retrieve it by snare catheter and patient have sent for the surgery." additional information that was received on 06/17/2019 from the foreign distributor: "balloon disconnected from the catheter and embolized to the descending aorta." "traumatic injury to right common iliac artery (during snaring of the balloon).Patient was transferred to or and procedure performed, identified the pin hole leak and repaired the was transferred to pcicu.While in pcicu; patient developed dic picture.".

• Brand Name: Z-5 ATRIOSEPTOSTOMY CATHETER
• Type of Device: SEPTOSTOMY CATHETER
• Manufacturer (Section D): NUMED CANADA, INC.; 45 second street west; cornwall, K6J 1 G3; CA K6J 1G3
• Manufacturer (Section G): NUMED CANADA, INC.; 45 second street west; cornwall, K6J 1 G3; CA K6J 1G3
• Manufacturer Contact: nichelle laflesh ; 45 second street west; cornwall, K6J 1-G3 ; CA K6J 1G3
• MDR Report Key: 8704543
• MDR Text Key: 148265719
• Report Number: 9618000-2019-00004
• Device Sequence Number: 1
• Product Code: DXF
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K960070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/31/2023
• Device Model Number: 210
• Device Catalogue Number: SPT003
• Device Lot Number: AS-2155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 1 DA
• Patient Weight: 3