MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-20 for PEDIASAT CUSTOM CATHETER XT248SJ manufactured by Edwards Lifesciences, Pr.
[139702804]
One 4. 5f (1. 5mm) double lumen pediasat catheter was returned for evaluation. As received, all extension tubes were cut off. A non-edwards cap was attached at the distal lumen hub and a three-way stopcock and non-edwards caps were attached at the proximal lumen hub. No visible damage at the catheter tip bond area was observed. No visible blood was observed in the optic fiber lumen where blood residues could remain if blood leaked into the optic fiber lumen. No visible damage to the catheter body was found except for the cut extension tubes confirmed to be cut by the customer when exchanging the catheter. Leak test was performed to both the distal and proximal extension tubes, and no leakage was observed. Optic module connector was opened for further examination. No abnormality or indication of leakage was observed inside the optic module connector. Visual examinations were performed under microscope at 10x magnification. The catheter was sent for further leak testing on the catheter body. A supplemental report will be sent with the additional evaluation results. A device history record review was completed and documented that device met all specifications upon distribution. Customer report could not be confirmed during the analysis, as the device responded appropriately during functional testing. There was no evidence of a manufacturing nonconformance. If a leak in the optical module connector is undetected at routine pre-insertion flushing, the catheter could leak during use and need to be removed/ exchanged for a new one. This could be done over a guidewire with minimal delay in therapy, and would not require a new venous access. These catheters, however, are used in pediatric patients, who have a lower threshold for brief interruptions in therapy or minor amounts of bleeding than adult patients. In this case, there were no patient complications reported. 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
[139702805]
It was reported that leakage of blood and medication was observed during use of a pediasat catheter while monitoring a (b)(6) old female patient in the icu. The leakage was confirmed from the optical module connector. The medicinal solution consisted of physio35 injection, dopamine hydrochloride, nitroglycerin, alprostadil alfadex and dexmedetomidine hydrochloride. The customer reported that all extension tubes (optical / distal / proximal) were cut off when the catheter was exchanged using a guidewire. There were no patient complications reported by the customer. No further information was able to be obtained at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2019-00951 |
| MDR Report Key | 8438364 |
| Date Received | 2019-03-20 |
| Date of Report | 2019-02-24 |
| Date of Event | 2019-02-23 |
| Date Mfgr Received | 2019-03-21 |
| Device Manufacturer Date | 2017-12-19 |
| Date Added to Maude | 2019-03-20 |
| 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. LYNN SELAWSKI |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9497564386 |
| 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 | PEDIASAT CUSTOM CATHETER |
| Generic Name | PEDIASAT CATHETER |
| Product Code | DQE |
| Date Received | 2019-03-20 |
| Returned To Mfg | 2019-03-06 |
| Model Number | XT248SJ |
| Lot Number | 61174889 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-03-20 |