MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-11 for MILLER BALLOON ATRIOSEPTOSTOMY CATHETER 830515F manufactured by Edwards Lifesciences, Pr.
[130491058]
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. The reported lot number was not able to be correlated to this product; therefore, a review of the manufacturing records could not be completed. 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 notes that during balloon testing and preparation, no more than 1ml of carbon dioxide or 2ml of saline should be used for testing and flushing the catheter, as large volumes will stretch the balloon and make insertion more difficult. Additionally, air should never be used in? Any? Instance because balloon rupture could produce a dangerous air embolus. Lastly, 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 Inflation should be discontinued and the catheter withdrawn immediately.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
[130491059]
It was reported that during use in a (b)(6) old infant, the balloon on a miller balloon atrioseptostomy catheter burst. The incident occurred at the end of the procedure when the balloon was inflated with 3ml of an unknown medium. Upon removal, it was noted that the balloon was very damaged, which raised concern there was a potential risk for embolization of balloon fragments. The use of another catheter was not needed, as the procedure was determined to have produced the desired result; however, considering the high risk of embolization, an electroencephalogram and transfontanelle ultrasonography were performed as follow-up. There was no patient injury nor reported complications as a result of the event. It was noted that the customer stated the issue could be related to the fact that the product was used 15 days past its expiration date, though it was later discovered that the reported expiration date was 06/26/2018 and the procedure was performed in mid-(b)(6) 2018. Additionally, the reported lot number does not correspond to the reported device. The device was discarded and not available for evaluation. Aside from the patient age, demographics are unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2018-05212 |
| MDR Report Key | 8153505 |
| Date Received | 2018-12-11 |
| Date of Report | 2018-11-20 |
| Date of Event | 2018-11-20 |
| Date Mfgr Received | 2018-12-13 |
| Device Manufacturer Date | 2017-03-30 |
| Date Added to Maude | 2018-12-11 |
| 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. 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 | 2018-12-11 |
| Model Number | 830515F |
| Catalog Number | 830515F |
| Lot Number | 60789508 |
| Device Expiration Date | 2018-06-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Other | 2018-12-11 |