MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2015-04-15 for ONYX AVM 105-7100-060 manufactured by Covidien (irvine).
[5644017]
Medtronic (covidien) received report that during a cerebral arteriovenous fistula / embolization, the scepter balloon catheter (terumo) got immobilized after injecting onyx and could not be removed from the patient. It seemed the onyx was adhered to the tip of the balloon catheter. The physician inflated the balloon of scepter balloon catheter and started injecting the onyx. Reflux of onyx at the proximal part of the balloon was confirmed but the davf was completely embolized. In order to remove the scepter balloon catheter, the physician used 4fr cerulean guiding catheter (b)(4) covered the clot of onyx, and removed from the patient. Upon removing the scepter with cerulean, the balloon of the scepter broke but it did not cause any harm or other malfunction.
Patient Sequence No: 1, Text Type: D, B5
[13133586]
The onyx will not be returned for evaluation as it was consumed in the event. Based on the reported information, there is no evidence suggesting that the onyx was defective, but rather a procedure related event. The lot history record of the reported lot number has been reviewed and no quality issues were noted. (b)(4). Additional information, was inadvertently selected and is not applicable, as this is an initial 30-day report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2029214-2015-00372 |
| MDR Report Key | 4694910 |
| Report Source | 01,05,06,07 |
| Date Received | 2015-04-15 |
| Date of Report | 2015-03-17 |
| Date of Event | 2015-03-12 |
| Date Mfgr Received | 2015-03-17 |
| Date Added to Maude | 2015-04-15 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. TRICHA MILES |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9496801224 |
| Manufacturer G1 | COVIDIEN (IRVINE) |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ONYX AVM |
| Generic Name | AGENT, INJECTABLE, EMBOLIC |
| Product Code | OBA |
| Date Received | 2015-04-15 |
| Model Number | 105-7100-060 |
| Lot Number | 9810775 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN (IRVINE) |
| Manufacturer Address | 9775 TOLEDO WAY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-04-15 |