MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-27 for MILLER BALLOON ATRIOSEPTOSTOMY CATHETER 830515F manufactured by Edwards Lifesciences, Pr.
[129062421]
Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor can a root cause or any potential contributing factors be identified. No actions will be taken at this time. A device history record review was completed and documented that the device met all specifications upon distribution. An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint. Invasive procedures involve some patient risks. Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use the catheter, to consider the potential benefits in relation to the possible complications. The techniques for insertion, methods of using the catheter to obtain patient data information, and the occurrence of complications is well described in the literature. The ifu cautions that with balloon inflation volumes above 4 ml, in-vitro laboratory tests indicated that there is a potential risk of balloon fragmentation with attendant loss of latex material. Inflation of the balloon is associated with a feeling of resistance. If no resistance is encountered and the balloon is not visualized with injection of the angiographic solution, it should be assumed that the balloon has a leak or has ruptured. Inflation should be discontinued and the catheter withdrawn immediately. As with all catheterization procedures, complications may occur. Perforation, arteriovenous fistula formation, plaque dissection, catheter tip separation, rhythm disturbances, infection, ductus arteriosus rupture, laceration of the atrioventricular valves, balloon fragment embolization, and failure of balloon deflation have all been reported incident to the use of atrioseptostomy catheters it is unknown if user or procedural factors contributed to this event. Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.
Patient Sequence No: 1, Text Type: N, H10
[129062422]
It was reported that during use of a miller balloon atrioseptostomy catheter in a rashkind catheterization on a one-day old female infant, the balloon burst. Prior to use in the patient, the balloon had been inflated with 1 to 3ml of physiological saline and then deflated in order to purge it and ensure there was no air. Under ultrasound guidance, the physician then? Mounted the catheter to the heart? And began to inflate the balloon and? Draw regularly? On the septum. When 1. 5ml of physiological saline was injected, the doctor? (as at previous "levels")? Tried to pull the septum. At that time, the ultrasound showed micro-bubbles of air in the heart, as well as dispersion of the physiological fluid. After removing the catheter, the team realized that the balloon was loosened at the base. Since the liquid within the balloon had spread into the heart, the physician felt there was a potential for the release of balloon pieces into the circulation, which would cause a high risk of embolism for the infant. Although there was no immediate clinical consequence for the patient, an eeg (electroencephalogram) and etf (transfontanellar ecography) were arranged to verify there were no consequences. A new catheter was used in order to continue with the procedure. It was confirmed on follow-up with the customer that the patient was reported to be well with no complications. Unfortunately, the suspect device was discarded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2018-04905 |
| MDR Report Key | 8108493 |
| Date Received | 2018-11-27 |
| Date of Report | 2018-11-08 |
| Date of Event | 2018-11-02 |
| Date Mfgr Received | 2018-11-08 |
| Device Manufacturer Date | 2017-08-11 |
| Date Added to Maude | 2018-11-27 |
| 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 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SAMANTHA EVELEIGH |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492503939 |
| Manufacturer G1 | EDWARDS LIFESCIENCES, PR |
| Manufacturer Street | STATE RD INDUS PK 402 KM 1.4 |
| Manufacturer City | ANASCO PR 00610 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00610 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MILLER BALLOON ATRIOSEPTOSTOMY CATHETER |
| Generic Name | CATHETER, SEPTOSTOMY |
| Product Code | DXF |
| Date Received | 2018-11-27 |
| Model Number | 830515F |
| Catalog Number | 830515F |
| Lot Number | 60977994 |
| Device Expiration Date | 2018-11-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES, PR |
| Manufacturer Address | STATE RD INDUS PK 402 KM 1.4 ANASCO PR 00610 US 00610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-27 |