MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-02 for HYPERGLIDE 104-4112 manufactured by Micro Therapeutics, Inc. Dba Ev3.
[182171726]
Since the device was not returned, we are unable to perform further root cause analysis and the exact cause of the reported event is unknown. All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture. No corrective action. Monitoring and trending this type of event. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182171727]
Medtronic received report that the pipeline flex with shield device did not open at the proximal section. The hyperglide balloon was selected to open the pipeline device. However, the balloon ruptured during the inflation. A new balloon was used to open the pipeline device. No patient injury occurred. The vessel anatomy was normal in tortuosity. The pipeline was place in a curb / bend in the anatomy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029214-2020-00179 |
| MDR Report Key | 9774241 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-02 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-02-12 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2019-06-15 |
| Date Added to Maude | 2020-03-02 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MGR. KATCHA TAYLOR |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9496801345 |
| Manufacturer G1 | MICRO THERAPEUTICS, INC. DBA EV3 |
| 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 | HYPERGLIDE |
| Generic Name | CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY |
| Product Code | MJN |
| Date Received | 2020-03-02 |
| Model Number | 104-4112 |
| Lot Number | A848770 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICRO THERAPEUTICS, INC. DBA EV3 |
| Manufacturer Address | 9775 TOLEDO WAY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-02 |