MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-12 for CELLO BALLOON GUIDE CATHETER 1610570 manufactured by Micro Therapeutics, Inc. Dba Ev3 Neurovascular.
[38751125]
The investigation is ongoing and the results will be sent upon completion.
Patient Sequence No: 1, Text Type: N, H10
[38751126]
Medtronic received information that at the conclusion of a vessel sacrifice procedure, the balloon of the cello balloon catheter became dislodged. The cello balloon catheter was used to perform balloon test occlusion and then it was used to deploy coils and plugs to sacfice the vessel without any issue. When the physician removed the cello from the touhy, the balloon fell off into the physician's hand. The balloon was discarded but the catheter is available for device analysis. No injury was reported as a result of this procedure.
Patient Sequence No: 1, Text Type: D, B5
[41968636]
Type of report - follow up type of report - device evaluation device evaluated by manufacturer - additional information: the cello balloon guide catheter was returned for analysis. The catheter was examined and the balloon assembly was found to be missing. As indicated in the complaint, the balloon was discarded at the site. No other anomalies were observed. The catheter investigation is ongoing and the results will be sent upon completion.
Patient Sequence No: 1, Text Type: N, H10
[45862563]
Device evaluation based on the reported information, device analysis and manufacturer investigation report, the customer? S report is confirmed. Per the manufacturer investigation report, the gluing part of the balloon for the distal and proximal side remained, but the useful length of the balloon was dislodged. According to the initial report, the balloon was used during the procedure without any issue and was dislodged during the removal from the patient. Based on this information, it is presumed that some loads were incidentally generated to the balloon part during removal which caused the balloon to fall off outside of the patient? S body. The cause of the loads could not be determined as the dislodged balloon was not returned. The lot history record review of the reported lot number showed no discrepancies that would have contributed to the reported experience.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2029214-2016-00087 |
| MDR Report Key | 5435659 |
| Date Received | 2016-02-12 |
| Date of Report | 2016-01-21 |
| Date of Event | 2016-01-21 |
| Date Mfgr Received | 2016-02-17 |
| Device Manufacturer Date | 2015-01-26 |
| Date Added to Maude | 2016-02-12 |
| 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 TOLDEO 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 | 2016-02-12 |
| Returned To Mfg | 2016-02-09 |
| Model Number | 1610570 |
| Lot Number | 5300307 |
| Device Expiration Date | 2016-09-01 |
| 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 TOLDEO WAY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-12 |