MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-21 for FOGARTY DILATION ATRIOSEPTOSTOMY CATHETER 830705F manufactured by Edwards Lifesciences, Pr.
[131931061]
Our product evaluation laboratory received one model 830705f catheter. The balloon was inflated with 3. 6cc of air and the balloon inflated concentric. Balloon deflation was achieved in 4 seconds, which was within the maximum specified deflation time with air. The balloon was again inflated using 1. 8cc of water and the balloon inflated concentric and did not leak. The balloon could not deflate completely after 15 seconds, which was out of the specified maximum deflation time with water. The balloon latex appeared deteriorated and discolored on the exposed balloon latex. The balloon latex under the balloon windings appeared to be in good condition. The balloon windings and balloon latex were removed to show the nylon yarn under the balloon latex. An unknown crystal was found filling up the gaps between the braided nylon yarn. The crystal appeared to restrict the inflation lumen. No visible damage or inconsistency was found from the catheter body. The unknown crystal was sent for chemistry analysis. Eds analysis detected the following elements present in the unknown material from glass slides: silicon, sodium, magnesium, chloride, phosphorus, zinc, potassium, calcium, sulfur, bromide, and iron. Eds analysis detected the following elements present on the balloon inflation port: silicon, magnesium, sodium, phosphorus, sulfur, chloride, potassium and calcium. The customer report of "would not inflate" was not confirmed on evaluation. A device history record review was completed and documented that the device met all specifications upon distribution. 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. As with all catheterization procedures, complications may occur. Perforation, arteriovenous fistula formation, venous thrombosis, catheter tip separation, rhythm disturbances, infection, damage of the atrioventricular valves, balloon fragment embolization, and failure of balloon deflation have all been reported incident to the use of atrioseptostomy catheters. It is common clinical practice to inspect the catheter and balloon prior to use on a patient. A balloon that does not inflate or deflate would be discovered upon inspection and the catheter can be exchanged with a minimal delay in treatment. The ifu states,? Care must be exercised to avoid damage to the balloon during insertion of the catheter?. If the balloon deflation difficulty is not discovered prior to use, blood flow could be compromised between the heart chambers. 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
[131931062]
It was reported that the balloon on a fogarty dilation atrioseptostomy catheter would not inflate. It is unknown if the issue occurred prior to or during use. There was no allegation of patient injury. Patient demographics were requested and not provided. No other details were able to be obtained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2018-05514 |
| MDR Report Key | 8189891 |
| Date Received | 2018-12-21 |
| Date of Report | 2018-08-23 |
| Date of Event | 2018-08-23 |
| Date Mfgr Received | 2018-12-13 |
| Device Manufacturer Date | 2017-12-16 |
| Date Added to Maude | 2018-12-21 |
| 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. 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 | FOGARTY DILATION ATRIOSEPTOSTOMY CATHETER |
| Generic Name | CATHETER, SEPTOSTOMY |
| Product Code | DXF |
| Date Received | 2018-12-21 |
| Returned To Mfg | 2018-11-28 |
| Model Number | 830705F |
| Catalog Number | 830705F |
| Lot Number | 61176182 |
| Device Expiration Date | 2019-03-14 |
| 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 | 2018-12-21 |