MAUDE Adverse Event Report: MEDTRONIC DOMINICANA CARDIAC/PERITONEAL CATHETER; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	43103
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information regarding a catheter.It was reported that a ventriculoperitoneal shunt (vp) was performed on (b)(6) 2024 with a diagnosis of non-communicating hydrocephalus.Asepsis was carried out using betadine and phenacaine injection.Then, incisions were made layer by layer at the incision markings in the cranial area, followed by incisions in the right hypochondrium area until the fascia was visible.Then a spanner was inserted from the abdomen to the cranium.The shunt tube was inserted from the cranium towards the abdomen and connected to the vp shunt chamber.After connecting, it appeared that the cerebrospinal fluid was not coming out at the proximal end, but at a proximal hole.The hole was 5 cm from the proximal end.The procedure was completed with back up products.The patient's status at the time of the report was alive-no injury.

• Brand Name: CARDIAC/PERITONEAL CATHETER
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer (Section G): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 19519101
• Report Number: 9612501-2024-01410
• Device Sequence Number: 6030763
• Product Code: JXG
• UDI-Device Identifier: 00763000028305
• UDI-Public: 00763000028305
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K792005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 43103
• Device Catalogue Number: 43103
• Device Lot Number: 0226370191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 06/12/2024
• Date Device Manufactured: 04/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female