MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-03 for SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER 774F75 manufactured by Edwards Lifesciences, Pr.
[140913583]
Our product evaluation laboratory received one model 774f75 catheter with a 1. 5cc syringe. The balloon was found to be ruptured around the circumference in the central area of the balloon latex. The latex edges did not seem to match at the ruptured region. All through lumens were patent without any leakage or occlusion. No other visible damage was observed from the catheter body. A device history record review was completed and documented that the device met all specifications upon distribution. The customer report of a balloon issue 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. It is standard 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. When there is separation of the balloon or fragments from the pulmonary artery catheter, the retained fragment will embolize to the lungs. Due to the large surface area of the pulmonary vasculature, this is generally well tolerated, but can lead to complications such as infection or small infarction. Pulmonary complications may result from improper inflation technique. To avoid damage to the pulmonary artery and possible balloon rupture, the balloon should not be inflated above the recommended volume. 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
[140913584]
It was reported that prior to insertion, the balloon on a swan-ganz catheter burst. A new device was used without issue. There was no patient injury. Patient demographics were requested and are unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2019-01168 |
| MDR Report Key | 8481163 |
| Date Received | 2019-04-03 |
| Date of Report | 2019-02-26 |
| Date of Event | 2019-02-24 |
| Date Mfgr Received | 2019-03-31 |
| Device Manufacturer Date | 2018-03-09 |
| 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 | SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER |
| Generic Name | CATHETER, OXIMETER, FIBEROPTIC |
| Product Code | DQE |
| Date Received | 2019-04-03 |
| Returned To Mfg | 2019-03-28 |
| Model Number | 774F75 |
| Catalog Number | 774F75 |
| Lot Number | 61286357 |
| 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 | 2019-04-03 |