MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-02 for MILLER BALLOON ATRIOSEPTOSTOMY CATHETER 830515F manufactured by Edwards Lifesciences, Pr.
[132348825]
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.
Patient Sequence No: 1, Text Type: N, H10
[132348826]
It was reported that the balloon on a miller balloon atrioseptostomy catheter detached during use in a (b)(6) male infant. The issue occurred while the balloon was inflated and being pulled through the right atrium of the heart. The balloon was left inside the infant? S right atrium and he was transferred to another hospital where he underwent a? Major invasive procedure with higher cost? In order to remove the detached balloon. As per follow-up, the infant was transferred back to the original treating hospital and was doing well after removal of the detached balloon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2019-00022 |
| MDR Report Key | 8210893 |
| Date Received | 2019-01-02 |
| Date of Report | 2018-12-13 |
| Date of Event | 2018-12-06 |
| Date Mfgr Received | 2019-02-14 |
| Device Manufacturer Date | 2018-04-20 |
| Date Added to Maude | 2019-01-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2019-01-02 |
| Returned To Mfg | 2019-01-15 |
| Model Number | 830515F |
| Catalog Number | 830515F |
| Lot Number | 61332460 |
| Device Expiration Date | 2019-07-13 |
| 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 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2019-01-02 |