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 Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the catheter was broken.There was no intervention performed or planned as the device did not have contact with the patient.As a result the procedure was completed with back up products.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported that the possible cause of the broken catheter was that the catheter was less strong when pulled.

• Brand Name: CARDIAC/PERITONEAL CATHETER, STANDARD, BARIUM IMPREGNATED, 90 CM
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8436441
• Report Number: 2021898-2019-00117
• Device Sequence Number: 18891956
• Product Code: JXG
• UDI-Device Identifier: 00643169466821
• UDI-Public: 00643169466821
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K792005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2019

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: 01/31/2023
• Device Model Number: 43103
• Device Catalogue Number: 43103
• Device Lot Number: E44322
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2019
• Supplement Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 05/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1