inforMED
MalfunctionGYK

CODMAN

Received Aug 26, 2022 · Event occurred Aug 10, 2022

Report 15300221 · MDR key 15300221

Device

Generic name

Instrument, Shunt System Implantation

Model number

831325

Catalog number

83-1325

Lot number

5955073

Product problems

  • Positioning Problem

Patient

7 DA · Female

  • Apnea
  • Low Oxygen Saturation
  • Diminished Pulse Pressure
  • Pneumoperitoneum
  • Apnea
  • Low Oxygen Saturation
  • Diminished Pulse Pressure
  • Pneumoperitoneum

Narrative

Description of Event or Problem

PATIENT WENT APENIC AND DESATED. PPV STARTED AND THEN HR DROPPED BELOW 60 AND CHEST COMPRESSIONS STARTED. NEONATAL TEAM CALLED TO ROOM. AFTER VENTRICULOPERITONEAL (VP) SHUNT SURGERY PATIENT DEVELOPED PNEUMOPERITONEUM. PATIENT TAKEN BACK TO OR WHERE THE VP SHUNT WAS FOUND TO BE THROUGH ANTERIOR AND POSTERIOR WALL OF STOMACH AT LESSER CURVATURE, AND THROUGH TRANSVERSE COLONIC MESENTERY. SHUNT REMOVED FROM STOMACH AND BOTH DEFECTS OVER SEWN. PATIENT HAD RETURNED FROM THE OR APPROXIMATELY 30 MINUTES PRIOR TO EVENT. TRANSITIONED TO NC (NASAL CANNULA), THEN WENT APNEIC. CODMAN SPLIT SHEATH TROCAR WENT THROUGH ANTERIOR AND POSTERIOR WALLS OF THE STOMACH. THE CATHETER INTRODUCER USED WAS THE SMALLER SIZE 12.5 FR. REF# 83-1325, LOT# 5955073 THIS DEVICE WAS DISPOSED OF.