MAUDE Adverse Event Report: RELIEVANT MEDSYSTEMS INC INTRACEPT ACCESS INSTRUMENTS - TROCAR; TROCAR INTRODUCER

Model Number	FG0045
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	11/02/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician had successfully completed cadaver training and was well versed in trans-pedicular access, having performed many kyphoplasty procedures and instrumented fusion surgeries.During the case, the physician approached the left l5 pedicle with the intracept introducer using an oblique en face view under c-arm fluoroscopic guidance.A lateral fluoroscopic image established that the tip of the introducer was ventral to the spinous process, and the surgeon removed the introducer.He re-initiated the procedure using a 22-gauge spinal needle as a guide.The remainder of the procedure went without incident, and the basivertebral nerves were successfully ablated on the left at l5 and the right at l4.There were no intra-operative or immediate post-operative signs or symptoms of complication noted.The surgeon contacted the territory manager stating that the patient was taken to the hospital with a retroperitoneal hematoma.Pt was transferred 4 1/2 hrs post op with hypotension to local trauma hospital.Got 5 units.Angio was negative and got some "iliolumbars" coils to be safe.Went home (b)(6) 2018.Only pain she had on that day was by the llq where the hematoma was.No reported back pain.

• Brand Name: INTRACEPT ACCESS INSTRUMENTS - TROCAR
• Common Device Name: TROCAR INTRODUCER
• Manufacturer (Section D): RELIEVANT MEDSYSTEMS INC; 385 moffett park drive; suite 105; sunnyvale CA 94089 1218
• MDR Report Key: 8102634
• Report Number: 3006789852-2018-00002
• Device Sequence Number: 11060527
• Product Code: GXI
• UDI-Device Identifier: 00852454006028
• UDI-Public: (01)00852454006028(17)191109(10)127331317A
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170827
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/26/2018

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: 11/09/2019
• Device Model Number: FG0045
• Device Catalogue Number: RLV AKT05
• Device Lot Number: 127331317A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 11/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTRACEPT FLEXIBLE BI-POLAR RF PROBE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR
• Patient Weight: 54