MAUDE Adverse Event Report: MRI INTERVENTIONS CLEARPOINT; HOLDER HEAD, NEUROLOGICAL STEREO TAXIC INSTRUMENT

Catalog Number NGS-SF-01-11

Device Problems Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problems Hemorrhage, Subdural (1894); Seizures (2063)

Event Date 09/24/2018

Event Type  Injury  

Event Description

During the procedure, the mri scanner table unexpectedly moved past iso center causing the drape to dislodge the smartframe stereotactic frame, breaking the inserted stylet.The stylet was removed without issue, a subsequent image was taken showing minor subdural bleeding.Cause of bleeding was not determined, patient was monitored for a period of time followed by the surgeon successfully completing the procedure.Shortly after the procedure the patient began to have seizures and was placed in medical induced state of unconsciousness.After approximately 1 week, the patient was awaken and is recovering well.Hospital engineering was made aware of the scanner table issue.

• Brand Name: CLEARPOINT
• Type of Device: HOLDER HEAD, NEUROLOGICAL STEREO TAXIC INSTRUMENT
• Manufacturer (Section D): MRI INTERVENTIONS; 5 musick; irvine CA 92618
• Manufacturer Contact: pete piferi ; 5 musick; irvine, CA 92618 ; 9499006833
• MDR Report Key: 7966143
• MDR Text Key: 123733261
• Report Number: 3002838670-2018-00003
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171257
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: NGS-SF-01-11
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other