MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2018-05-01 for EPSTAXIS CATHETER EP0050 manufactured by Smiths Medical, Asd, Inc..
[107028703]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[107028704]
It was reported that when installing a smiths medical epistaxis catheter, there was a tendency of the device to leak in the back groove. The patient experienced respiratory distress. There was failure of the anterior balloon to deflate, which had been inflated with sterile water. The posterior balloon deflated without any problem. Actions were taken in the care facility for the patient's management - placement of a wick, stopping the epistaxis. The event was resolved.
Patient Sequence No: 1, Text Type: D, B5
[110236029]
One epistaxis was returned for analysis in used condition with fluid in the large proximal cuff. Using a syringe, this fluid was removed. Visual inspection of the epistaxis noted no obvious anomalies. Functional testing included inflation and mechanical testing. Using a standard syringe, 10cc's of water was inserted into the small proximal cuff. The cuff inflated fully and remained inflated while pressure was applied to the cuff. Using a standard syringe, 30cc's of water was inserted into the large proximal cuff. The cuff inflated fully and remained inflated while pressure was applied to the cuff. The device was submerged under water and inspected for leaks while manipulating the device and squeezing the cuffs. No leaks were evident. The device was removed from the water and allowed to rest for twenty-four hours with the cuffs inflated; the cuffs remained inflated. The device was manipulated and pressure applied to both cuffs. No leaks were evident. Using a syringe, 10 cc's of water was removed from the small distal cuff and 30 cc's of water was removed from the large proximal cuff. The cuffs were inflated and deflated three additional times without issues. Based on the evidence, the complaint was unable to be confirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3012307300-2018-01340 |
| MDR Report Key | 7477171 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2018-05-01 |
| Date of Report | 2018-06-06 |
| Date of Event | 2018-02-07 |
| Date Mfgr Received | 2018-05-10 |
| Device Manufacturer Date | 2015-07-30 |
| Date Added to Maude | 2018-05-01 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833310 |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC. |
| Manufacturer Street | 5700 WEST 23RD AVENUE |
| Manufacturer City | GARY IN 46406 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46406 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EPSTAXIS CATHETER |
| Generic Name | BALLOON, EPISTAXIS |
| Product Code | EMX |
| Date Received | 2018-05-01 |
| Returned To Mfg | 2018-04-19 |
| Catalog Number | EP0050 |
| Lot Number | 2990012 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL, ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-01 |