MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-03 for TIGERPAW SYSTEM II TP15AJ07 manufactured by Laax Inc.
[23377769]
Health hazard eval (hhe) was completed.
Patient Sequence No: 1, Text Type: N, H10
[23377770]
Distal pins of the tigerpaw system ii device were not engaged. These pins were not on tissue. A looped suture was used to complete procedure to secure closure of left atrium appendage. No known blood lost or injury referred to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008788191-2015-00071 |
| MDR Report Key | 4972797 |
| Date Received | 2015-08-03 |
| Date of Report | 2014-05-30 |
| Date of Event | 2014-05-28 |
| Date Mfgr Received | 2014-05-30 |
| Device Manufacturer Date | 2013-06-01 |
| Date Added to Maude | 2015-08-05 |
| 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 | LIOUDMILA MODYLEVSKAIA |
| Manufacturer Street | 151 LINDBERGH AVE STE I |
| Manufacturer City | LIVERMORE CA 94551 |
| Manufacturer Country | US |
| Manufacturer Postal | 94551 |
| Manufacturer Phone | 9254494108 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1461-2015 Z-1462-2015 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TIGERPAW SYSTEM II |
| Generic Name | STAPLE, IMPLANTABLE |
| Product Code | CDW |
| Date Received | 2015-08-03 |
| Model Number | TP15AJ07 |
| Lot Number | 0853M |
| Device Expiration Date | 2016-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LAAX INC |
| Manufacturer Address | LIVERMORE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-03 |