MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-02 for FOGARTY DILATION ATRIOSEPTOSTOMY CATHETER 830705F manufactured by Edwards Lifesciences, Pr.
[122635036]
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. A device history record review was completed and documented that the device met all specifications upon distribution. 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[122635037]
It was reported that the balloon on a 5f fogarty atrioseptostomy catheter detached from the shaft during an emergent, life-saving procedure on a weeks old infant. Fortunately the physician was able to remove the catheter and the balloon without any complications. There was no patient injury. Additional patient demographics and operative report were requested and not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2018-04004 |
| MDR Report Key | 7926688 |
| Date Received | 2018-10-02 |
| Date of Report | 2018-09-10 |
| Date of Event | 2018-09-10 |
| Date Mfgr Received | 2018-10-04 |
| Device Manufacturer Date | 2018-03-15 |
| Date Added to Maude | 2018-10-02 |
| 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 | 2018-10-02 |
| Returned To Mfg | 2018-10-03 |
| Model Number | 830705F |
| Catalog Number | 830705F |
| Lot Number | 61270367 |
| Device Expiration Date | 2019-06-11 |
| 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 | 2018-10-02 |