MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-21 for MILLER BALLOON ATRIOSEPTOSTOMY CATHETER 830515F manufactured by Edwards Lifesciences, Pr.
[131930797]
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
[131930798]
It was reported that the balloon on a miller balloon atrioseptostomy catheter burst during use in a rashkind catheterization procedure on a 4kg newborn male patient. The device was checked prior to insertion and difficulties to inflate and deflate the balloon were noticed at that time. The physician proceeded to use the catheter and the balloon was inflated with 1ml for the first pass, which was performed without any issues. The balloon burst after the second pass, when the balloon was inflated with 2ml, releasing microbubbles and contrast medium into the heart. The device was not replaced for another one since the procedure was concluded. Due to concern there could be a potential risk of gas embolism, a transformanellar ultrasonography was planned for the patient; however, the customer was unresponsive to requests for the results. The customer reported there were no clinical consequences observed for the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2018-05525 |
| MDR Report Key | 8190928 |
| Date Received | 2018-12-21 |
| Date of Report | 2018-12-05 |
| Date of Event | 2018-12-04 |
| Date Mfgr Received | 2019-01-09 |
| Device Manufacturer Date | 2018-09-23 |
| Date Added to Maude | 2018-12-21 |
| 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 | PHARMACIST |
| 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 | 2018-12-21 |
| Returned To Mfg | 2018-12-26 |
| Model Number | 830515F |
| Catalog Number | 830515F |
| Lot Number | 61516358 |
| Device Expiration Date | 2019-12-21 |
| 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. Other | 2018-12-21 |