MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2018-07-03 for VOLUME VIEW CATHETER VLV8R416 manufactured by Edwards Lifesciences, Pr.
[113283398]
Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor can a root cause or any potential contributing factors be identified. No actions will be taken at this time. The lot number was not provided; therefore, a review of the manufacturing records could not be completed. An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint. Invasive procedures involve some patient risks. Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use the catheter, to consider the potential benefits in relation to the possible complications. The techniques for insertion, methods of using the catheter to obtain patient data information, and the occurrence of complications is well described in the literature. In this case, the patient required a new stick to insert a new catheter. It is unknown if user or procedural factors may have contributed to this 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
[113283399]
It was reported that during use of a volume view catheter in (b)(6) year-old male patient, an error message? Check catheter temperature probe connection? Was displayed on the monitor. The connection was checked and noted to be fine. Troubleshooting the message indicated there was either a problem with the temperature cable or a problem with the catheter. The cable and the ev1000 monitor were changed, but the issue remained. Replacing the volume view device for another one resolved the issue. This resulted in a new stick into the opposite femoral artery for insertion of the new volume view set. There was no allegation of patient injury. The device was discarded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2018-02607 |
| MDR Report Key | 7659969 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2018-07-03 |
| Date of Report | 2018-06-04 |
| Date of Event | 2018-06-04 |
| Date Mfgr Received | 2018-06-15 |
| Date Added to Maude | 2018-07-03 |
| 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 | 3 |
| Brand Name | VOLUME VIEW CATHETER |
| Generic Name | PROBE, THERMODILUTION |
| Product Code | KRB |
| Date Received | 2018-07-03 |
| Model Number | VLV8R416 |
| Catalog Number | VLV8R416 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-07-03 |