MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-24 for SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER 774F75 manufactured by Edwards Lifesciences, Pr.
[143059093]
One catheter with attached monoject 1. 5 cc limited volume syringe was returned for evaluation. A non-edwards contamination shield was located on the catheter body between 62. 5 cm and 89 cm proximal from the catheter tip. Balloon inflated, but resistance was felt when air was injected into balloon lumen. The balloon remained inflated for more than 5 minutes without leakage. It took 10. 5 seconds for balloon deflation without the syringe attached and it was out of specification. The specification for balloon deflation without a syringe attached is 4 seconds. A stylet wire was passed from the gate valve to around the catheter tip. The cut down found that an unknown material (less than 0. 5 mm x 0. 5mm) were observed near the inflation port. No visible damage or deterioration was found from balloon. All through lumens were patent without any leakage or occlusion. No other visible damage to the catheter body was found. The material was sent to chemistry for testing. Balloon inflation test was performed using returned syringe with 1. 5 cc air. Visual examination was performed under microscope at 20x magnification 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. A supplemental report will be sent with the chemistry investigation results. In this evaluation, it is reported that the balloon deflation time was out of specification. During patient use, balloon deflation difficulty may result in an occlusion of blood flow and can result in distal ischemia. It can result in the physician intentionally over-inflating the balloon to burst. In this event, there was no patient compromise as an inflation difficulty was noted with the balloon before use. 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
[143059094]
It was reported that the balloon on the swan ganz did not inflate at the inflation test 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 | 2015691-2019-01459 |
| MDR Report Key | 8546673 |
| Date Received | 2019-04-24 |
| Date of Report | 2019-02-21 |
| Date of Event | 2019-02-21 |
| Date Mfgr Received | 2019-05-02 |
| Device Manufacturer Date | 2018-12-03 |
| Date Added to Maude | 2019-04-24 |
| 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 | 2019-04-24 |
| Returned To Mfg | 2019-03-10 |
| Model Number | 774F75 |
| Catalog Number | 774F75 |
| Lot Number | 61708870 |
| 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 | 2019-04-24 |