MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for COOK CELECT? PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET G34505 IGTCFS-65-1-UNI-CELECT-PT manufactured by William Cook Europe.
[188823887]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188823888]
As initially reported to customer relations via phone discussion with the customer: female patient underwent a filter implant on (b)(6) 2015 in which the cook celect platinum navalign uniset vena cava filter set, (b)(4), was used. The patient presented for an unrelated issue to the hospital on (b)(6) 2019 which the physician ordered a ct scan. During the ct scan it was discovered that the tip of the filter had fractured and separated and penetrated the aorta. One leg perforated the left renal, one perforated the right kidney, and one is in the l4 vertebral body. No removal procedures to be done related to this however, due to patients overall general health status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005580113-2020-00316 |
| MDR Report Key | 9898099 |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2019-12-06 |
| Date Facility Aware | 2020-03-13 |
| Report Date | 2020-03-30 |
| Date Reported to FDA | 2020-03-30 |
| Date Reported to Mfgr | 2020-03-30 |
| Device Manufacturer Date | 2015-08-31 |
| Date Added to Maude | 2020-03-30 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK CELECT? PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET |
| Generic Name | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR |
| Product Code | DTK |
| Date Received | 2020-03-30 |
| Model Number | G34505 |
| Catalog Number | IGTCFS-65-1-UNI-CELECT-PT |
| Lot Number | E3362007 |
| Device Expiration Date | 2018-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WILLIAM COOK EUROPE |
| Manufacturer Address | SANDET 6 BJAEVERSKOV 4632 DA 4632 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2020-03-30 |