MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-01-15 for SWAN-GANZ TRUE SIZE THERMODILUTION CATHETER 096F6J manufactured by Edwards Lifesciences, Pr.
[188654339]
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
[188654340]
It was reported that the balloon of the swan ganz catheter was ruptured and detached from the catheter during use. The results of x-ray showed no missing balloon remained in the patient body. Patient demographic information requested but unavailable. There were no patient complications reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2020-10189 |
| MDR Report Key | 9592634 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-01-15 |
| Date of Report | 2019-12-25 |
| Date of Event | 2019-12-25 |
| Date Mfgr Received | 2019-12-25 |
| Date Added to Maude | 2020-01-15 |
| 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. JESSICA ATALLAH |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492500249 |
| 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 TRUE SIZE THERMODILUTION CATHETER |
| Generic Name | SWAN-GANZ CATHETER |
| Product Code | DYG |
| Date Received | 2020-01-15 |
| Model Number | 096F6J |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-01-15 |