MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-05-14 for TRIOX? SVO2 PA CATHETER P7110-EP8-H, 8F, 110CM, EXTRA PORT, HEPARIN COATED 50328-07 manufactured by Icu Medical, Inc..
[145775611]
The reported complaint of the catheter being difficult to retract through the concomitant device could not be confirmed. The partial 30 cm portion of the triox catheter, which appears to have been cut, was visually examined and no surface anomalies, stretch marks or indentations were observed across the catheter. The investigation found no evidence the partially returned device components, features and or functions caused or contributed to the event. The catheter was measured length wise and there was no indication that it was stretched during use. The outer diameter of both the balloon and the catheter were measured and both meet product specifications. The remaining 80 cm of catheter, the hub and the proximal tubing connectors were not returned for investigation. The returned cordis device was also examined and no visually anomalies were observed that could have prevented extracting the catheter. The 30 cm portion of the catheter was pushed into the introducer and was able to be retracted without difficulty. The reported complaint could not be replicated with the indentured partial catheter and introducer. Additionally, the event describes what appears to be a? Knotting? Condition which is a known inherent risk associated with this procedure. Knotting can occur with any flow-directed pulmonary artery catheter. The directions for use (dfu) addresses this condition and provides instructions, recommendations and clinical references that would address this occurrence.
Patient Sequence No: 1, Text Type: N, H10
[145775612]
User facility medwatch was received that stated the following:? Anesthesia provider was inserting a pulmonary artery catheter when it became difficult to retract. The catheter could be advanced, just not retracted. The inability to place the catheter in the desired anatomical position resulted in the anesthesia provider attempting to withdraw the catheter. The catheter could not be discontinued and removed without the cordis as well?. It was also reported that the event occurred during insertion of a pulmonary artery catheter. There was no adverse event reported. No additional information is known at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1713468-2019-00015 |
| MDR Report Key | 8609087 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-14 |
| Date of Report | 2019-04-22 |
| Date of Event | 2019-02-18 |
| Date Mfgr Received | 2019-05-10 |
| Device Manufacturer Date | 2019-01-01 |
| Date Added to Maude | 2019-05-14 |
| 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 | EMILY ARNOULD |
| Manufacturer Street | 600 N. FIELD DR. |
| Manufacturer City | LAKE FOREST IL 60045 |
| Manufacturer Country | US |
| Manufacturer Postal | 60045 |
| Manufacturer Phone | 2247062300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIOX? SVO2 PA CATHETER P7110-EP8-H, 8F, 110CM, EXTRA PORT, HEPARIN COATED |
| Generic Name | CATHETERS AND ACCESSORIES |
| Product Code | DQE |
| Date Received | 2019-05-14 |
| Returned To Mfg | 2019-04-29 |
| Catalog Number | 50328-07 |
| Lot Number | 3914350 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ICU MEDICAL, INC. |
| Manufacturer Address | 4455 S. ATHERTON DRIVE SALT LAKE CITY UT 84123 US 84123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-14 |