MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-16 for SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER 777F8 manufactured by Edwards Lifesciences, Pr.
[139185555]
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. The lot number was not provided; therefore, a review of the manufacturing records could not be completed.
Patient Sequence No: 1, Text Type: N, H10
[139185556]
It was reported to the edwards rep that a swan-ganz catheter failed prior to insertion. The pulmonary artery pressure (pap), even after zeroing on the monitor, went to 27/27. It was then noticed that the balloon was failing to remain inflated when tested. There was no patient injury. Another swan was placed and worked fine. The model and lot number were unknown. Patient demographics were requested and not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2019-00908 |
| MDR Report Key | 8427005 |
| Date Received | 2019-03-16 |
| Date of Report | 2019-02-22 |
| Date of Event | 2019-02-22 |
| Date Mfgr Received | 2019-03-28 |
| Device Manufacturer Date | 2018-07-23 |
| Date Added to Maude | 2019-03-16 |
| 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 | MS. SAMANTHA EVELEIGH |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492503939 |
| 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 | 0 |
| Brand Name | SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER |
| Generic Name | CATHETER, OXIMETER, FIBEROPTIC |
| Product Code | DQE |
| Date Received | 2019-03-16 |
| Returned To Mfg | 2019-03-25 |
| Model Number | 777F8 |
| Catalog Number | 777F8 |
| Lot Number | 61453932 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-03-16 |