MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-21 for SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER 777F8 manufactured by Edwards Lifesciences, Pr.
[139815608]
One catheter with attached monoject 1. 5 cc volume limited syringe and two three-way stopcocks was returned for evaluation. A non-edwards contamination shield was located on the catheter body between 68 cm and 84 cm proximal from the catheter tip. Balloon did not inflate due to leakage from a tear, approximately 0. 5 mm x 5 mm, at the central side of the balloon latex. The latex edges were not able to match up. No visible damage was noted on the catheter body under the balloon latex. All through lumens were patent without any leakage or occlusion. No other visible damage or abnormality to the catheter body or returned syringe was observed. Balloon inflation test was performed using returned syringe with 1. 5 cc air by holding the balloon under water. Visual examination was performed under microscope at magnification 20x. A device history record review was completed and documented that device met all specifications upon distribution. Customer report of balloon inflation issue was confirmed during the analysis. An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions. 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. It is common clinical practice to check balloon integrity by inflating it to the recommended volume in order to detect any asymmetry or leakage condition before use of the catheter. It is unknown if user or procedural factors may have contributed to the event. This incident occurred before use so there was no patient compromise noted. 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
[139815609]
It was reported that the balloon of the swan ganz catheter did not inflate before use. Patient demographic information requested but unavailable. There were no patient complications reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2019-00975 |
| MDR Report Key | 8441310 |
| Date Received | 2019-03-21 |
| Date of Report | 2019-01-23 |
| Date of Event | 2019-01-22 |
| Date Mfgr Received | 2019-02-28 |
| Device Manufacturer Date | 2018-10-28 |
| Date Added to Maude | 2019-03-21 |
| 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. 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 | SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER |
| Generic Name | SWAN-GANZ CATHETER |
| Product Code | DQE |
| Date Received | 2019-03-21 |
| Returned To Mfg | 2019-02-13 |
| Model Number | 777F8 |
| Catalog Number | 777F8 |
| Lot Number | 61579280 |
| 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 | 2019-03-21 |