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 2020-01-06 for SWAN-GANZ THERMODILUTION PACEPORT CATHETER 931F75 manufactured by Edwards Lifesciences, Pr.
[188675189]
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
[188675190]
It was reported that during use of a swan-ganz catheter, the balloon was unable to be passively deflated after 1. 5 ml of air was injected. The balloon had successfully been inflated/deflated prior insertion. Upon removal, the balloon appeared intact and could be inflated and deflated? Without concerns.? There was no patient injury. Patient demographics were requested and not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2020-10055 |
| MDR Report Key | 9555907 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-06 |
| Date of Report | 2019-12-17 |
| Date of Event | 2019-12-17 |
| Date Mfgr Received | 2020-01-16 |
| Device Manufacturer Date | 2019-03-31 |
| Date Added to Maude | 2020-01-06 |
| 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 | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492500294 |
| 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 THERMODILUTION PACEPORT CATHETER |
| Generic Name | ELECTRODE, PACEMAKER, TEMPORARY |
| Product Code | LDF |
| Date Received | 2020-01-06 |
| Returned To Mfg | 2020-01-10 |
| Model Number | 931F75 |
| Lot Number | 62065217 |
| 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 | 2020-01-06 |