MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-02-29 for CELLO BALLOON GUIDE CATHETER 1610580 manufactured by Micro Therapeutics, Inc. Dba Ev3 Neurovascular.
[39249725]
The device will not be returned for analysis as it was discarded; therefore the complaint could not be determined. Same event as reported in mdr mfr: 2029214-2016-00120.
Patient Sequence No: 1, Text Type: N, H10
[39249726]
Medtronic received information that during a mechanical thrombectomy procedure in the internal carotid artery (ica), the cello balloon burst and leaked upon inflation. No patient injury as a result of this event. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029214-2016-00121 |
| MDR Report Key | 5466967 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-02-29 |
| Date of Report | 2016-02-03 |
| Date of Event | 2016-01-27 |
| Date Mfgr Received | 2016-02-03 |
| Device Manufacturer Date | 2015-11-17 |
| Date Added to Maude | 2016-02-29 |
| 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 | TRICHA MILES |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9498373700 |
| Manufacturer G1 | MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CELLO BALLOON GUIDE CATHETER |
| Generic Name | CATHETER, NEURO-VASCULATURE, OCCLUDING BALLON |
| Product Code | NUF |
| Date Received | 2016-02-29 |
| Model Number | 1610580 |
| Lot Number | 5500188 |
| Device Expiration Date | 2018-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR |
| Manufacturer Address | 9775 TOLEDO WAY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-29 |