MAUDE Adverse Event Report: MRI INTERVENTIONS INC MRII TWIST DRILL; CRANIAL DRILL

Model Number	ED-800047
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	03/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no suggestion by the health professionals that the twist drill or drill bits failed to meet specification.Product not returned.
Event or Problem Description
The twist drill was used to prepare 3.4 mm pilot hole, followed by a 4.5 mm bit to provide larger access to the frontal lobe lesion.During biopsy of the lesion, it was noted that there was a larger than normal amount of blood.Subsequent mri scans confirmed some blood in the subarachnoid space and subdural.The case was aborted.Patient was removed from the mri scanner, into the operating room for a craniotomy to remove the blood.On the subsequent friday the (b)(6), patient presented hemiplegic, with re-accumulation of blood visible on ct, so a second craniotomy was performed.The patient is doing well, with no expected continued deficit.

• Brand Name: MRII TWIST DRILL
• Common Device Name: CRANIAL DRILL
• Manufacturer (Section D): MRI INTERVENTIONS INC; 5 musick; irvine CA 92618
• MDR Report Key: 6517011
• Report Number: 1125732-2017-00001
• Device Sequence Number: 1201942
• Product Code: HBG
• UDI-Device Identifier: 00850359007034
• UDI-Public: 00850359007034
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: ED-800047
• Device Catalogue Number: NGS-HG-01
• Device Lot Number: FA1610030
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2017
• Initial Report FDA Received Date: 04/24/2017
• 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: Required Intervention
• Patient Age: 55 YR