MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY ARES ANTIBIOTIC-IMPREGNATED CATHETER KIT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	95001
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/15/2019
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 intra-operative drainage test found that the drainage was not smooth.The antimicrobial catheters were replaced with another ventricular and cardiac/peritoneal catheter which their function was normal, and then another set of antimicrobial catheters which their function was also normal.
Additional Manufacturer Narrative
The returned device included part number (pn) 17358-1 ventricular catheter and pn 17359-1 cardiac/peritoneal catheter.47 inches of the cardiac/peritoneal catheter was returned.The cardiac/peritoneal catheter met the requirements for leak, patency and tensile testing.The ventricular catheter was returned in two segments, the longest being 5.4 inches and the other being 2.4 inches.Due to the length of the ventricular catheter that was returned, only one tensile test could be performed.The sample of the ventricular catheter that was tested met the requirements for tensile testing.The ventricular catheter could not be tested for leak and patency due to the damage.Three of the ends of the two segments returned were damaged.It is unknown how or when this damage occurred.The instruction for use cautions, ¿improper use of instruments in handling or implanting shunt products may result in the cutting, slitting or crushing of components.Such damage may lead to loss of shunt integrity¿¿ proteinaceous debris was observed on the ventricular catheter and the peritoneal catheter.The instructions for use cautions, ¿shunt obstruction may occur in any component of the shunt system.The ventricular catheter may become occluded by particulate matter (e.G.Blood clots, brain fragments, and bacterial colonization), by investment of the catheter tip in choroid plexus, by embedding of the catheter in brain tissue, or by coaptation of the ventricular walls in the presence of overdrainage (¿slit ventricles¿).¿ all catheters are 100% inspected at the time of manufacture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ARES ANTIBIOTIC-IMPREGNATED CATHETER KIT
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8378780
• Report Number: 9612164-2019-00731
• Device Sequence Number: 16647852
• Product Code: JXG
• UDI-Device Identifier: 00643169762664
• UDI-Public: 00643169762664
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K110560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2019

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: 08/29/2019
• Device Model Number: 95001
• Device Catalogue Number: 95001
• Device Lot Number: 0009010741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2019
• Supplement Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR