AGILIS NXT, 8.5F. STEERABLE INTRODUCER, SMALL CURL Adverse Event — Malfunction (MDR 2182269-2008-00060)
AGILIS NXT, 8.5F. STEERABLE INTRODUCER, SMALL CURL Adverse Event — Malfunction (MDR 2182269-2008-00060) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: AGILIS NXT, 8.5F. STEERABLE INTRODUCER, SMALL CURL; Generic name: AGILIS NXT, 8.5F; Manufacturer: ST. JUDE MEDICAL.
| Device | AGILIS NXT, 8.5F. STEERABLE INTRODUCER, SMALL CURL |
|---|---|
| Generic name | AGILIS NXT, 8.5F |
| Manufacturer | ST. JUDE MEDICAL |
| Report number | 2182269-2008-00060 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-21 |
| Report source | Health Professional, User facility, Company representation |
| Narrative | IT WAS REPORTED THE PHYSICIAN CROSSED THE SEPTUM AND WHEN HE ASPIRATED THE SHEATH, THERE WAS AIR IN THE SYSTEM. THE SHEATH APPEARS AS IF IT HAS STRETCHED AT THE SEAM, JUST DISTAL TO THE HANDLE. THERE WAS NO PT INJURY REPORTED. |
| Source | openFDA MAUDE (device adverse events) |
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