MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY EXACTA EXTERNAL DRAINAGE AND MONITORING SYSTEM; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Model Number	46700
Medical Device Problem Codes	Break (1069); Disconnection (1171); Fracture (1260); Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received regarding a patient undergoing drilling and drainage surgery for treatment of a chronic subdural hematoma.It was reported that, after opening the package when the doctor grabbed the tip of the drainage system and connected it to the tip of the catheter, the drainage system anti-pressure tube and tee shunt in the patient's end fell off, causing it to be contaminated.As a result the device was replaced.The device did not have contact with the patient, but resulted in a 10 minute extended surgery time.
Additional Manufacturer Narrative
The returned product was returned with the patient line disconnected at the patient line stopcock.The lab personnel was able to reconnect the patient line for testing.No damage was observed.The device met the requirements for leak and patency testing.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.

• Brand Name: EXACTA EXTERNAL DRAINAGE AND MONITORING SYSTEM
• Common Device Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8500818
• Report Number: 2021898-2019-00147
• Device Sequence Number: 11452774
• Product Code: GWM
• UDI-Device Identifier: 00643169707665
• UDI-Public: 00643169707665
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K983799
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/08/2023
• Device Model Number: 46700
• Device Catalogue Number: 46700
• Device Lot Number: 216327428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 05/03/2019; 05/15/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 05/03/2019; 05/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1