MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2019-02-07 for Z-5 ATRIOSEPTOSTOMY CATHETER 210 SPT003 manufactured by Numed Canada, Inc..
[135403268]
A sample from the same lot was pull tested for strength. The sample first failed at the balloon with a pull strength of 42. 18 newtons. The catheter was tested again and the catheter shaft failed at 60. 49 newtons. This is well above the acceptance criteria called out in the bench testing (minimum of 8. 9 newtons at all test locations). The catheter was being used in a patient that was (b)(6) according to the report from the physician. There is a precaution in the instructions for use that states: "balloon atrioseptostomy should not be performed for infants older than six weeks. These infants will have thick atrial septums. Reference aha/acc guidelines. " potential balloon separation with subsequent need of snare is a listed potential complication of the procedure in the ifu. There is also an additional warning that states: "the use of excessive force to pull the balloon across the atrial septum must be avoided. " in the insertion: vascular section that warning is again stated and is followed by "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. The amount of fluid can be gradually increased in volume until the desired result is achieved. If the first two steps are not successful, consider static balloon dilation of the atrial septum. It states in the report from the physician that only one attempt was made and it is unknown as to what volume was used. It was a normal syringe filled by hand.
Patient Sequence No: 1, Text Type: N, H10
[135403269]
As per the report from the physician/foreign distributor: "during the rashkind procedure (pulling a balloon filled in the left vestibule of the heart to the right atrium of the heart), the distal part of the catheter to atrioseptomy was separated (along with a filled balloon). A filled balloon was baring in the right atrium of the heart. The separated distal part of the catheter together with the balloon was captured in the anatomy of the right atrium of the heart of the loops for removing foreign bodies from the cardiovascular system and brought to the right iliac vein and then removed surgically. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9618000-2019-00001 |
| MDR Report Key | 8315853 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2019-02-07 |
| Date of Report | 2019-02-07 |
| Date of Event | 2018-12-19 |
| Date Mfgr Received | 2019-01-17 |
| Device Manufacturer Date | 2017-10-24 |
| Date Added to Maude | 2019-02-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NICHELLE LAFLESH |
| Manufacturer Street | 45 SECOND STREET WEST |
| Manufacturer City | CORNWALL, ONTARIO K6J 1G3 |
| Manufacturer Country | CA |
| Manufacturer Postal | K6J 1G3 |
| Manufacturer G1 | NUMED CANADA, INC. |
| Manufacturer Street | 45 SECOND STREET WEST |
| Manufacturer City | CORNWALL, ONTARIO K6J 1G3 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | K6J 1G3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | Z-5 ATRIOSEPTOSTOMY CATHETER |
| Generic Name | SEPTOSTOMY CATHETER |
| Product Code | DXF |
| Date Received | 2019-02-07 |
| Returned To Mfg | 2019-01-25 |
| Model Number | 210 |
| Catalog Number | SPT003 |
| Lot Number | AS-2126 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUMED CANADA, INC. |
| Manufacturer Address | 45 SECOND STREET WEST CORNWALL, ONTARIO K6J 1G3 CA K6J 1G3 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-07 |