MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-04-20 for N/A R10439011 manufactured by Sterilmed, Inc..
[106137270]
The device has not yet been returned to the manufacturer at the time of this report. A supplemental form will be sent once the evaluation is completed if the device is returned. The device history was unable to be reviewed as no lot not was supplied by the customer for this device. Additional products in use were: carto 3 system ser# 11415; smart touch catheter: cat# d134805; pentaray catheter: cat# d128211. Manufacturer's ref no: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[106137271]
It was reported that a male patient underwent an atrial fibrillation (afib) procedure with a soundstar eco 8f diagnostic ultrasound imaging catheter and developed pericardial effusion and torsades de points requiring cardiopulmonary resuscitation (cpr) to stabilize and pericardiocentesis. During the transseptal phase, effusion occurred while working in the right ventricle (rv). Torsades de points was detected. Cpr was performed to stabilize the patient followed by pericardiocentesis. Patient required transfer to the critical care unit (ccu) for observation. Patient status improved after the adverse event. It is unknown whether the quadriplegic state of the patient may have contributed to the adverse event. Physician did provide a causality opinion; that the soundstar in the rv caused the effusion. There were no reported malfunctions with soundstar catheter. There were no issues or errors reported on any generators or equipment during the procedure. Transeptal puncture was performed with an unknown transeptal needle and a slo curve type saint jude medical 8. 5 sheath. Generator was set on smart ablate at 40 watts. Anticoagulation was provided to the patient during the procedure. Activated clotting time (act) was maintained at 300-350. The power was not titrated during ablation. The overall ablation time at the site of injury was 3 hours. There is no further information regarding generator parameters, generator settings, power titration, or last ablation cycle time at the site of injury. Irrigated catheter flow was set at high. There was no noted catheter proximity during the event. The catheter was not zeroed after the initial warm-up phase post catheter connection to the carto 3 patient interface unit (piu). There is no information regarding shaft proximity or interference value.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2018-00001 |
| MDR Report Key | 7447834 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-04-20 |
| Date of Report | 2018-03-21 |
| Date of Event | 2018-02-16 |
| Date Mfgr Received | 2018-03-21 |
| Date Added to Maude | 2018-04-20 |
| 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 | GABRIEL ALFAGEME |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 949789-868 |
| Manufacturer G1 | STERILMED, INC. |
| Manufacturer Street | 5010 CHESHIRE PARKWAY STE 2 |
| Manufacturer City | PLYMOUTH MN 55446 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55446 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | N/A |
| Generic Name | IMAGING CATHETER |
| Product Code | OWQ |
| Date Received | 2018-04-20 |
| Model Number | R10439011 |
| Catalog Number | R10439011 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 5010 CHESHIRE PARKWAY STE 2 PLYMOUTH MN 55446 US 55446 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2018-04-20 |