MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-02-20 for EMBOSPHERE MICROSPHERES V820GH manufactured by Biosphere Medical Sa.
[67802255]
A follow up will be submitted upon completion of the investigation. Device is a permanent implant.
Patient Sequence No: 1, Text Type: N, H10
[67802256]
The account alleges that the patient presented with significant post-abortion hemorrhaging, hypoxemia and medial thoracic chest pain. The patient was diagnosed with a ruptured uterine arteriovenous malformation and an emergent embolization of the patient's trophoblastic tissue bilaterally was performed. During embolic administration the patient continued to experience chest pain. The procedure was stopped for administration of basic life support and resuscitation by the code team. The patient was transferred to an intensive care unit for recovery. The patient received intravenous blood transfusions in the unit.
Patient Sequence No: 1, Text Type: D, B5
[73681972]
Additional information was received from the account. The patient has totally recovered from this incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615728-2017-00001 |
| MDR Report Key | 6342762 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-02-20 |
| Date of Report | 2017-01-27 |
| Date of Event | 2017-01-26 |
| Date Mfgr Received | 2017-03-29 |
| Device Manufacturer Date | 2016-07-05 |
| Date Added to Maude | 2017-02-20 |
| 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 | MR CASEY HUGUES, MS, CQE |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN, UT, 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8013164932 |
| Manufacturer G1 | BIOSPHERE MEDICAL |
| Manufacturer Street | PARC DES NATIONS, PARIS NORD 2 383, RUE DE LA BELLE ETOILE |
| Manufacturer City | ROISSY EN FRANCE, FRANCE 95700 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 95700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMBOSPHERE MICROSPHERES |
| Generic Name | EMBOSPHERE MICROSPHERES |
| Product Code | NAJ |
| Date Received | 2017-02-20 |
| Catalog Number | V820GH |
| Lot Number | X971247 |
| Device Expiration Date | 2019-05-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOSPHERE MEDICAL SA |
| Manufacturer Address | PARC DES NATIONS, PARIS NORD 2 383, RUE DE LA BELLE ETOILE ROISSY EN FRANCE, FRANCE 95700 FR 95700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2017-02-20 |