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 2020-01-17 for SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER 774F75 manufactured by Edwards Lifesciences, Pr.
[188655563]
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 was completed and documented that the device met all specifications upon distribution.
Patient Sequence No: 1, Text Type: N, H10
[188655565]
It was reported that during the insertion of a swan-ganz catheter, the hemodynamic pressure displayed too high. No error message or alarm was displayed. The issue persisted after re-zeroing the device. It was not known what the expected values were based on the patient status at the time of the event. It was also not known if the patient was treated according to the displayed value. The issue was solved by replacing the device. It was noted that the pulmonary artery pressure (pap) displayed by the second device was approximately 12-13 mmhg and remained the same after re-zeroing. There was no allegation of patient injury. Patient demographics were requested and are unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2020-10230 |
| MDR Report Key | 9602568 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-17 |
| Date of Report | 2020-01-02 |
| Date of Event | 2019-11-11 |
| Date Mfgr Received | 2020-01-02 |
| Device Manufacturer Date | 2019-05-12 |
| Date Added to Maude | 2020-01-17 |
| 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 V CCO/SVO2/CEDV THERMODILUTION CATHETER |
| Generic Name | CATHETER, OXIMETER, FIBEROPTIC |
| Product Code | DQE |
| Date Received | 2020-01-17 |
| Returned To Mfg | 2020-02-27 |
| Model Number | 774F75 |
| Catalog Number | 774F75 |
| Lot Number | 62199498 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2020-01-17 |