MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-18 for MILLER BALLOON ATRIOSEPTOSTOMY CATHETER 830515F manufactured by Edwards Lifesciences, Pr.
[133849066]
The product is expected to be returned for analysis; however, it has not yet been received. Additionally, a device history record review has been initiated to ensure that the device met all specifications upon distribution. A supplemental report will be sent with the investigation results.
Patient Sequence No: 1, Text Type: N, H10
[133849067]
It was reported that during use of an atrioseptostomy catheter in a 5 days-old infant, the balloon was inflated with 2ml of air but failed to deflate after pulling it from the left atrium (la) to the right atrium (ra). In order to retrieve the catheter, the physician used a 10ml syringe and performed multiple inflation and deflation attempts. He also pulled the balloon into the inferior vena cava (ivc) to compress the balloon and additional saline was pushed into the balloon. No further intervention was required. There was no patient injury and the infant was reported to be doing well after the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2019-00226 |
| MDR Report Key | 8262957 |
| Date Received | 2019-01-18 |
| Date of Report | 2018-12-31 |
| Date of Event | 2018-12-30 |
| Date Mfgr Received | 2019-02-13 |
| Device Manufacturer Date | 2018-09-23 |
| Date Added to Maude | 2019-01-18 |
| 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 | RISK MANAGER |
| 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 | 2019-01-18 |
| Returned To Mfg | 2019-01-19 |
| Model Number | 830515F |
| Catalog Number | 830515F |
| Lot Number | 61516358 |
| 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 | 2019-01-18 |