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.
[132044788]
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
[132044789]
It was reported that on (b)(6) 2018, the balloon on a miller balloon atrioseptostomy catheter failed to deflate during use in a (b)(6) old male infant. The issue occurred upon pulling back the catheter from the patient. It was clarified that the device was tested prior to use without problems. According to surgeon, there was no injury during the incident but unfortunately, the infant developed severe pulmonary hypertension (pht) post-procedure and subsequently deceased on (b)(6) 2018. It was noted by the surgeon that the severe pht that led to the infant? S death was not related to nor alleged to have resulted from the issue with the suspect catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2019-00023 |
| MDR Report Key | 8210896 |
| Date Received | 2019-01-02 |
| Date of Report | 2018-12-13 |
| Date of Event | 2018-12-05 |
| Date Mfgr Received | 2019-03-08 |
| Device Manufacturer Date | 2018-06-23 |
| 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 | 61408923 |
| 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 | 2019-01-02 |