MAUDE Adverse Event Report: MERMAID MEDICAL A/S M-BIOPSY® SEMI AUTOMATIC BIOPSY INSTRUMENT; SEMI AUTOMATIC BIOPSY INSTRUMENT 20GX10CM

Catalog Number	N30120010
Health Effect - Clinical Code	Death (1802)
Date of Event	06/04/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
This report is submitted to late with reference to fda 5 day report.However, we haven´t submitted the report since we have a clinical medical officer and the involved doctors that confirm that this incident is not related to the use of the product.It was shown on both patient, by ct scan after the death, that they have air embolism in the lung, which is the cause of death.The doctor has informed that there was no problem using the product, and it worked accordingly.The reason we submit now is that our notified body, (b)(6), during a annual audit informed that they believe this should have been reported.According 21 cfr §803.20 (2) we found that we did not needed to report this event, based on clinical study literature, which our clinical medical officer has found and analysed.The documentation show that in 3,8% of these procedures their is problem with air embolism.Furthermore, it also show that it is important that the patient is laid on their bag and is angled so that the biopsy area is lower than left atrium.This procedure was not followed at the hospital.Mermaid medical (b)(4) conclude that the incident is not caused by the use of our product.We have been informed from the hospital that they still use the product and that they have changed their process, all is working fine now.We hereby close the case.
Event or Problem Description
2 patients have died after a lung biopsy.First patient died 10 sec.After the biopsy and the second patient died 60 seconds after the 2nd biopsy.No abnormal occurence occured in the procedure and the biopsy needle worked as intended.

• Brand Name: M-BIOPSY® SEMI AUTOMATIC BIOPSY INSTRUMENT
• Common Device Name: SEMI AUTOMATIC BIOPSY INSTRUMENT 20GX10CM
• Manufacturer (Section D): MERMAID MEDICAL A/S; frydensbergvej 25; stenløse, 3360 ; DA 3360
• MDR Report Key: 8780012
• Report Number: 3007146453-2018-00005
• Device Sequence Number: 1937619
• Product Code: KNW
• UDI-Device Identifier: 15711055002339
• UDI-Public: 15711055002339
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K161409
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/02/2020
• Device Catalogue Number: N30120010
• Device Lot Number: P000472
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Five-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death