MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-03-29 for HYPERFORM 104-4470 manufactured by Micro Therapeutics, Inc. Dba Ev3 Neurovascular.
[41341216]
The device will not been returned for analysis; therefore the complaint cause could not be determined. If the device is returned a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[41341217]
Medtronic received information the during procedure after balloon inflation, the balloon would not deflate even with removal of the microguide wire. No patient injury was reported. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029214-2016-00180 |
| MDR Report Key | 5531551 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-03-29 |
| Date of Report | 2017-12-11 |
| Date of Event | 2016-02-23 |
| Date Mfgr Received | 2017-12-08 |
| Device Manufacturer Date | 2015-03-03 |
| Date Added to Maude | 2016-03-29 |
| 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 NEUROVASCULAR |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE CA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYPERFORM |
| Generic Name | CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY |
| Product Code | NUF |
| Date Received | 2016-03-29 |
| Returned To Mfg | 2017-11-29 |
| Model Number | 104-4470 |
| Lot Number | A067213 |
| Device Expiration Date | 2017-06-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-03-29 |