MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-05-09 for TD CATHETER, 7F, 4 LUMEN, 110 CM, HEPARIN COATED, LF 412290402 manufactured by Icu Medical, Inc..
[145775442]
The device is expected to return for evaluation. It has not been received.
Patient Sequence No: 1, Text Type: N, H10
[145775443]
User facility voluntary medwatch report mw5085197 was received that stated the following:? Right heart catheter inserted, when catheter was in pulmonary wedge position, user was unable to pull blood from inner lumen. Catheter was removed and noted to have ruptured balloon tip?. It was additionally indicated that there was no adverse event, but there was a serious injury that required intervention. No additional information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1713468-2019-00014 |
| MDR Report Key | 8596114 |
| Report Source | USER FACILITY |
| Date Received | 2019-05-09 |
| Date of Report | 2019-04-22 |
| Date of Event | 2019-02-06 |
| Date Mfgr Received | 2019-06-07 |
| Device Manufacturer Date | 2018-07-01 |
| Date Added to Maude | 2019-05-09 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EMILY ARNOULD |
| Manufacturer Street | 600 N. FIELD DR. |
| Manufacturer City | LAKE FOREST IL 60045 |
| Manufacturer Country | US |
| Manufacturer Postal | 60045 |
| Manufacturer Phone | 2247062300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TD CATHETER, 7F, 4 LUMEN, 110 CM, HEPARIN COATED, LF |
| Generic Name | CATHETER, OXIMETER, FIBER-OPTIC |
| Product Code | DQE |
| Date Received | 2019-05-09 |
| Catalog Number | 412290402 |
| Lot Number | 90-997-SJ |
| Device Expiration Date | 2019-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ICU MEDICAL, INC. |
| Manufacturer Address | 4455 S. ATHERTON DRIVE SALT LAKE CITY UT 84123 US 84123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-09 |