MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN HOLTER; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 82-1676

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 08/06/2019

Event Type  malfunction  

Event Description

A young patient with history of right porencephalic cyst with communication to his ventricular system & subsequent shunted hydrocephalus.In past, he failed both ventriculoperitoneal shunt (vps) & ventriculopleural shunt due to pseudocyst formation/malabsorption.Most recent shunt revision was conversion to right side ventriculoatrial shunt.Pt was evaluated through physical medicine clinic & had x-rays to eval for potential scoliosis, which incidentally revealed that ventriculoatrial shunt had fractured with tubing dislodged into his left pulmonary artery.Branch.Echo showed fragment of catheter in left pulmonary artery.A few weeks later, cardiology removed the fragmented piece successfully in cath lab.

• Brand Name: CODMAN HOLTER
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9450849
• MDR Text Key: 170291474
• Report Number: 9450849
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 82-1676
• Device Catalogue Number: 821676
• Device Lot Number: CMMC33
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/03/2019
• Event Location: Other
• Date Report to Manufacturer: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 3650 DA
• Patient Weight: 32