MAUDE Adverse Event Report: COVIDIEN LLC VENTRICULAR CATHETER; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	41101
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a catheter being used in a procedure.It was reported that the catheter was broken.During the ventriculoperitoneal shunted surgery in the operating room the catheter was found broken during the process of implanting.The health care professional used another catheter of the same model to performed the remained of the procedure.There was no reported impact to the patient.
Additional Manufacturer Narrative
Patient weight not available from the site.No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VENTRICULAR CATHETER
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13772097
• Report Number: 9612501-2022-00411
• Device Sequence Number: 12010415
• Product Code: JXG
• UDI-Device Identifier: 00763000028039
• UDI-Public: 00763000028039
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K792007
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/15/2022

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 Expiration Date: 01/14/2026
• Device Model Number: 41101
• Device Catalogue Number: 41101
• Device Lot Number: 0221628171
• 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: 03/14/2022
• Initial Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2021
• 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 Age: 47 YR
• Patient Sex: Female