MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-12 for FOGARTY DILATION ATRIOSEPTOSTOMY CATHETER 830705F manufactured by Edwards Lifesciences, Pr.
[114425982]
The product is expected to be returned for analysis; however, it has not yet been received. Upon the return of the product a supplemental report will be sent with the investigation results. The lot number was not provided; therefore, a review of the manufacturing records could not be completed.
Patient Sequence No: 1, Text Type: N, H10
[114425983]
It was reported that during use of a septostomy catheter, the interventional cardiologist experienced a balloon deflation issue while it was inside the pediatric patient (age unknown). The patient had transposition of the great arteries and balloon septostomy was performed at the bedside using echocardiogram guidance. The physician noted the procedure was otherwise routine and he "would have done one more pullback, but the septum was adequately opened. " troubleshooting included using the stiff end of a "018 wholey wire" in an attempt to perforate the balloon. The balloon was then pulled into the ivc, which the physician thought? May have helped compress it some.? There was no patient injury or consequence. Patient demographics were requested but not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2018-02781 |
| MDR Report Key | 7683216 |
| Date Received | 2018-07-12 |
| Date of Report | 2018-06-27 |
| Date of Event | 2018-06-13 |
| Date Mfgr Received | 2018-10-31 |
| Date Added to Maude | 2018-07-12 |
| 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 | FOGARTY DILATION ATRIOSEPTOSTOMY CATHETER |
| Generic Name | CATHETER, SEPTOSTOMY |
| Product Code | DXF |
| Date Received | 2018-07-12 |
| Returned To Mfg | 2018-08-17 |
| Model Number | 830705F |
| Catalog Number | 830705F |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-07-12 |