MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-27 for SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER 774F75 manufactured by Edwards Lifesciences, Pr.
[140536508]
One catheter with detached monoject 1. 5 cc limited volume syringe was returned for evaluation. Balloon was found to be torn and missing at the central area of the balloon latex. Both balloon bonding sites were partially missing. All through lumens were patent without any leakage or occlusion. No other visible damage to the catheter body or returned syringe was observed. Visual examination was performed under microscope at magnification 20x and with the unaided eyes. A device history record review was completed and documented that device met all specifications upon distribution. Customer report of balloon 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
[140536509]
It was reported that the balloon of the swan ganz catheter ruptured at the balloon test prior to insertion before use. The catheter was exchanged and the problem was solved. Patient demographic information requested but unavailable. There were no patient complications reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2019-01056 |
| MDR Report Key | 8458529 |
| Date Received | 2019-03-27 |
| Date of Report | 2019-02-20 |
| Date of Event | 2019-02-20 |
| Date Mfgr Received | 2019-03-05 |
| Device Manufacturer Date | 2018-10-25 |
| Date Added to Maude | 2019-03-27 |
| 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 THOMAS |
| 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 THERMODILUTION CATHETER |
| Generic Name | SWAN-GANZ CATHETER |
| Product Code | DQE |
| Date Received | 2019-03-27 |
| Returned To Mfg | 2019-03-03 |
| Model Number | 774F75 |
| Catalog Number | 774F75 |
| Lot Number | 61553183 |
| 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 | 2019-03-27 |