MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2010-01-16 for EVICEL (FACTOR I - FIBRINOGEN) PLS SEE NARRATIVE manufactured by Omrix Biopharmaceuticals Ltd., Sheba Hospital.
[1443471]
A serious spontaneous report regarding a (b)(6) male patient who developed air embolism after being treated with evicel via an air pressure device, during surgery for a laparoscopic partial nephrectomy. The case was reported by a physician via a sales rep. The pt was reported to be relatively fit and well but had a history of wolff parkinson white syndrome. He was currently being treated medically; however, the medication for this syndrome and other concomitant medications was not provided. It was reported that the pt had been very stable throughout the surgery. The renal artery had been clamped prior to evicel application. Within 2-3 mins of application of evicel using the gas injector (with the tip within 1 cm to the surface of the resected renal margin), the pt became very unstable. There was a sudden drop in the pt's oxygen saturation from 99% to 85%. This was also associated with a fall by 30-40% in the pt's end-tidal co2 (etco2). His blood pressure remained unchanged and his heart rate was initially unchanged, then fell and his rhythm changed from sinus to bigeminy. The treating surgeon felt this could be either a equipment problem, lung collapse, tube misplacement / dislodgement, anaphylaxis, fibrin embolus, air embolus or a cardiac condition. The pt was given 100% oxygen and was then off the ventilator and manually ventilated. Lung compliance was normal. Auscultation of the chest was normal with good air entry throughout and no wheeze or signs of pneumothorax. The anaesthetist responsible for the pt, noticed the emboli and started to deflate the insufflated gas from the surgical field. An external jugular vein line was already in situ and this was aspirated, initially blood then air was aspirated. At this time, the surgeon was not sure whether this was entrained air from the syringe becoming loose but in retrospect, the surgeon felt this was most likely to be true aspiration. This air amounted to approx 15 mls. At first, the surgeon did not have time to listen for a millwheel murmur. Intravenous glycopyrrolate at 200mcg was given slowly. This had good effect for the bigeminy. The pt returned to sinus rhythm. Over the next 3-5 minutes, there was a steady rise in the pt's oxygen saturation and etco2. Blood samples were taken for mast cell tryptase tests to exclude on allergic cause but the history strongly suggested gas embolus. Results of the tryptase test were not provided. It was reported that the pt did make a full and uneventful recovery with no sequelae. The reporter considered the event to be related to the pressure of application. The company physician assessed the causality as related to the use of the pressure regulator. Details of the device are : 5 ml device: (b)(4); 1/2ml: (b)(4); 35 cm: (b)(4); 45cm: (b)(4); pressure regulator: (b)(4). Application device: (b)(4); pressure regulator: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[8341987]
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Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003183625-2010-00001 |
| MDR Report Key | 1581097 |
| Report Source | 01,05,06,07 |
| Date Received | 2010-01-16 |
| Date of Report | 2010-01-15 |
| Date of Event | 2009-12-17 |
| Date Added to Maude | 2011-04-11 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVICEL (FACTOR I - FIBRINOGEN) |
| Generic Name | PRESSURE REGULATOR DEVICE |
| Product Code | BXX |
| Date Received | 2010-01-16 |
| Model Number | PLS SEE NARRATIVE |
| Catalog Number | PLS SEE NARRATIVE |
| Lot Number | PLS SEE NARRATIVE |
| ID Number | PLS SEE NARRATIVE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OMRIX BIOPHARMACEUTICALS LTD., SHEBA HOSPITAL |
| Manufacturer Address | MDA BLOOD BANK RAMAT GAN 52621 IS 52621 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-01-16 |