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 2020-01-07 for SWAN-GANZ BIPOLAR PACING CATHETER FOR FEMORAL INSERTION PE075F5 manufactured by Edwards Lifesciences, Pr.
[188675612]
No product was returned for evaluation; it was discarded at the hospital due to infection. Without the return of the product, it is not possible to determine if damages or defects existed on the product. A device history record review was completed and documented that device met all specifications upon distribution. No actions will be taken at this time. Swan-ganz pacing thermodilution (td) catheters serve as diagnostic and therapeutic tools in the management of critically ill patients. There are multiple failure modes that may require the exchange of a pacing catheter. Since proper functioning of the pacing catheter depends on the electrical continuity of its electrodes and internal wires, care should be exercised when handling the catheter. Stretching, kinking, or forceful wiping of the catheter may result in damage. After stable pacing has been confirmed, the proximal end of the catheter should be secured to the insertion site to prevent undue movement that could result in tip dislodgment and loss of capture, or catheter migration. Care should be taken not to kink the catheter body when securing it. In this complaint, it could not be determined if procedural factors or device handling may have contributed to the reported event. Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.
Patient Sequence No: 1, Text Type: N, H10
[188675613]
It was reported that the swan ganz catheter was unable to pace with an external pacemaker from the beginning of use after catheter insertion. The catheter was replaced and the problem was solved. It is unknown if the patient had cardiac conduction defect or not. Patient demographic information requested but unavailable. There were no patient complications reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2020-10064 |
| MDR Report Key | 9559012 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-01-07 |
| Date of Report | 2019-12-16 |
| Date of Event | 2019-12-16 |
| Date Mfgr Received | 2019-12-16 |
| Device Manufacturer Date | 2018-12-10 |
| Date Added to Maude | 2020-01-07 |
| 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. 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 BIPOLAR PACING CATHETER FOR FEMORAL INSERTION |
| Generic Name | PACING CATHETER |
| Product Code | LDF |
| Date Received | 2020-01-07 |
| Model Number | PE075F5 |
| Lot Number | 61719569 |
| 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 | 2020-01-07 |