MAUDE Adverse Event Report: FERROSAN MEDICAL DEVICES A/S SURGIFOAM ABSORBABLE GELATIN POWDER ; SURGIFOAM POWDER

Device Problem Insufficient Information (3190)

Patient Problems Hematoma (1884); Swelling (2091); Reaction (2414); Respiratory Failure (2484)

Event Type  Injury  

Event Description

As the mfr we received on (b)(6) 2015 from our distributor, ethicon, info regarding an literature article, "acute respiratory failure from surgifoam expansion after anterior cervical surgery": a (b)(6) woman underwent an uneventful c3-4 anterior cervical discectomy and fusion for a large, symptomatic disc herniation.On postoperative day 1 the pt suffered a sudden, acute respiratory compromise.Emergency fiberoptic intubation revealed significant anterior neck swelling with concern for physical obstruction of the airway.Computed tomography of the neck did not demonstrate and expanding hematoma.The pt was managed with surgical wound exploration and washout.Examination of the anterior neck after incision of the prior surgical site revealed a large volume of surgifoam under high pressure, which was greater than the amount used during the initial surgery.Thorough washout of the surgical site did not reveal any swelling of the prevertebral soft tissues or hematoma, and the hemovac drain did not appear to be occluded.The pt was extubated on the 2nd postoperative day and is symptom free 12 months after surgery.To the authors' knowledge, this report represents the first reported complication of acute respiratory failure from surgifoam overexpansion after anterior cervical surgery.The exact product code and lot no.Is not known.

Manufacturer Narrative

Gathering of additional info is being initiated.

Manufacturer Narrative

Evaluation and conclusion of the event: the patient experienced respiratory failure as a consequence of prevertebral and left neck-soft tissue swelling.A possible reason for the swelling could be that the surgifoam powder which was used to achieve hemostasis was not rinsed away properly following hemostasis and may have contributed to the event as the product swelled.

• Brand Name: SURGIFOAM ABSORBABLE GELATIN POWDER
• Type of Device: SURGIFOAM POWDER
• Manufacturer (Section D): FERROSAN MEDICAL DEVICES A/S; sydmarken 5; soeborg 2860 ; DA 2860
• Manufacturer Contact: sydmarken 5; soeborg 2860
• MDR Report Key: 4877833
• MDR Text Key: 5866314
• Report Number: 3008478369-2015-00005
• Device Sequence Number: 1
• Product Code: LMF
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Distributor,distributor,literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 65 YR