MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CARDIAC/PERITONEAL CATHETER, STANDARD, BARIUM IMPREGNATED, 90 CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 43103

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/29/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was diagnosed with a left occipital arachnoid cyst 6 years ago after it was found upon admission after a car accident.The patient underwent peritoneal shunt surgery.On (b)(6) 2020, the patient was admitted to the hospital for examination, and the peritoneal catheter was found to be broken in the body.The catheter had broke at the neck.The broken catheter was removed; however, a part of the broken catheter was left in the abdominal cavity.The patient's status at the time of the report was alive-no injury.There were no environmental/external/patient factors that may have led or contributed to the issue, and it did not pose a risk to the patient; however, it was stated that the physician was unable to determine.

• Brand Name: CARDIAC/PERITONEAL CATHETER, STANDARD, BARIUM IMPREGNATED, 90 CM
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 10323554
• MDR Text Key: 200392809
• Report Number: 2021898-2020-00205
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K792005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/24/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 43103
• Device Catalogue Number: 43103
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 07/24/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 26 YR
• Patient Weight: 70