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U.S. Department of Health and Human Services

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

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MRI INTERVENTIONS INC MRII TWIST DRILL CRANIAL DRILL Back to Search Results
Model Number ED-800047
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intracranial Hemorrhage (1891)
Event Date 03/08/2017
Event Type  Injury  
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 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.
 
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Brand NameMRII TWIST DRILL
Type of DeviceCRANIAL DRILL
Manufacturer (Section D)
MRI INTERVENTIONS INC
5 musick
irvine CA 92618
Manufacturer Contact
peter piferi
5 musick
irvine, CA 92618
9499006833
MDR Report Key6517011
MDR Text Key73556906
Report Number1125732-2017-00001
Device Sequence Number1
Product Code HBG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160129
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 04/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2018
Device Model NumberED-800047
Device Catalogue NumberNGS-HG-01
Device Lot NumberFA1610030
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/24/2017 Patient Sequence Number: 1
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