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

Model Number	43103
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Abdominal Pain (1685); Dizziness (2194)
Date of Event	09/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that 2 years after surgery, the catheter at the end of the abdominal cavity broke, and the broken part fell into the abdominal cavity.The patient experienced dizziness and stomach pain.The ventriculoperitioneal shunt was performed again where the shunt was taken out.It was indicated that the broken pieces that remained inside the patient's body were retrieved.The patient's vital signs were stable and conscious after the surgery.
Additional Manufacturer Narrative
The returned cardiac/peritoneal catheter was found to be broken in two pieces.No signs of biological debris were found on the body of the catheter.No signs of breakage was found within the individual segments of the catheters.Individual segments of the catheter were found to pass leakage testing and were patent.The catheter as a whole will not pass requirement of leakage as it was returned broken in two pieces.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported that the family members of the patient denied that the catheter was broken due to external and patient factors.It was noted that the patient was bedridden for a long time and had limited mobility.

• Brand Name: CARDIAC/PERITONEAL CATHETER, STANDARD, BARIUM IMPREGNATED, 90 CM
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• MDR Report Key: 12453404
• Report Number: 2021898-2021-00164
• Device Sequence Number: 4067634
• Product Code: JXG
• UDI-Device Identifier: 00643169466821
• UDI-Public: 00643169466821
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K792005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 43103
• Device Catalogue Number: 43103
• Device Lot Number: E52384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2021
• Supplement Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 09/10/2021
• Supplement Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 25 YR
• Patient Weight: 60