MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY PERITONEAL CATHETER WITH BIOGLIDE, STANDARD, 90 CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 93522

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported after the valve was installed and after the pressure was adjusted to 0.5, the patient still had poor drainage.The doctor suspected that the catheter was blocked so the abdominal catheter was removed during the surgery.It was noted that cerebrospinal fluid did not flow out of the abdominal end when the patient was in lying position.However, when the patient's head was lifted about 30 degrees, cerebrospinal fluid flew out of the abdominal end.It was noted the pressure of the valve was not adjusted during this process.As a result, the doctor suspected that the valve provided additional resistance in the supine position resulting in cerebrospinal fluid not flowing out.

Manufacturer Narrative

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

Event Description

Additional information received reported there were no environmental/external/patient factors that may have led or contributed to the issue.Temporarily, there are no actions/interventions taken to resolve the issue; however, the subsequent plan was to change to a va shunt.

• Brand Name: PERITONEAL CATHETER WITH BIOGLIDE, STANDARD, 90 CM
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 7635263305
• MDR Report Key: 9508151
• MDR Text Key: 174317825
• Report Number: 2021898-2019-00462
• 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,Followup
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 93522
• Device Catalogue Number: 93522
• Device Lot Number: F30011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2019
• 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