MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-03 for PRESEP CENTRAL VENOUS OXIMETRY KIT X3820ST manufactured by Edwards Lifesciences, Pr.
[141181914]
Our product evaluation laboratory received 2 images for review. Image 1 showed a section of guidewire, guidewire advancer and tubing. Blood was visible on the tubing. Image 2 showed the guidewire was broken into halves. A device history record review was completed and documented that the device met all specifications upon distribution. The customer report of a broken guidewire was confirmed on evaluation. 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. The suggested insertion procedure section of the ifu advises:? D. Insert the desired tip (straight or? J? ) of a guidewire into the placed catheter or, if used, the thin-wall needle. Gentle manipulation may be needed to insert the guidewire. The guidewire should never be forced. If difficulty is met during insertion of the guidewire, completely withdraw the guidewire and reattempt insertion. Caution: to avoid possible severing of the guidewire, do not withdraw against the needle bevel. This can result in the need for an additional percutaneous intervention to retrieve the guidewire. Caution: do not withdraw a ptfe-coated guidewire through a metal needle as this may damage the guidewire coating, potentially resulting in an embolism.? It is unknown whether user or procedural factors contributed to the stated 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
[141181915]
It was reported that the physician stated the guidewire on a presep catheter broke. The device was exchanged for a catheter from another brand without further issue. There was no patient injury. Patient demographics were requested and not provided. It is unknown if the issue occurred before or during use and no further details are known at this time. The catheter will not be returned for evaluation; however, the customer provided images of the suspect device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2019-01169 |
| MDR Report Key | 8481168 |
| Date Received | 2019-04-03 |
| Date of Report | 2019-03-27 |
| Date of Event | 2019-02-28 |
| Date Mfgr Received | 2019-05-21 |
| Device Manufacturer Date | 2018-05-07 |
| Date Added to Maude | 2019-04-03 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | PRESEP CENTRAL VENOUS OXIMETRY KIT |
| Generic Name | CATHETER, OXIMETER, FIBEROPTIC |
| Product Code | DQE |
| Date Received | 2019-04-03 |
| Returned To Mfg | 2019-05-21 |
| Model Number | X3820ST |
| Catalog Number | X3820ST |
| Lot Number | 61351099 |
| 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 | 2019-04-03 |