MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-23 for SWAN-GANZ CCOMBO CCO/SVO2 THERMODILUTION CATHETER 774F75 manufactured by Edwards Lifesciences, Pr.
[188656258]
The product is expected to be returned for analysis; however, it has not yet been received. Upon the return of the product a supplemental report will be sent with the investigation results. A device history record review has been initiated and a supplemental report will be sent with the investigation results.
Patient Sequence No: 1, Text Type: N, H10
[188656259]
It was reported that during use of a swan-ganz catheter, the central venous pressure (cvp) and the pulmonary artery pressure (pap) values were double. As per follow-up with the customer, it was clarified that the values were higher than the normal range and what was expected, based on the patient? S status. The issue was solved by replacing the catheter. No further information was available regarding if there was an error message displayed or any other details about this event. There was no patient injury and the patient was not treated according to the displayed values.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2020-10255 |
| MDR Report Key | 9622616 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-23 |
| Date of Report | 2020-01-07 |
| Date of Event | 2020-01-07 |
| Date Mfgr Received | 2020-01-20 |
| Date Added to Maude | 2020-01-23 |
| 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 | MS. LYNN THOMAS |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9497564386 |
| Manufacturer G1 | EDWARDS LIFESCIENCES, PR |
| Manufacturer Street | STATE RD INDUS PK 402 KM 1.4 |
| Manufacturer City | ANASCO PR 00610 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00610 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SWAN-GANZ CCOMBO CCO/SVO2 THERMODILUTION CATHETER |
| Generic Name | CATHETER, FLOW DIRECTED |
| Product Code | DYG |
| Date Received | 2020-01-23 |
| Model Number | 774F75 |
| Catalog Number | 774F75 |
| Lot Number | 62399257 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES, PR |
| Manufacturer Address | STATE RD INDUS PK 402 KM 1.4 ANASCO PR 00610 US 00610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-23 |