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	07/28/2018
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 the catheter would not allow cerebrospinal fluid to flow.It was stated the product had been implanted and the drainage was not smooth.The product was replaced and the patient¿s status was listed as alive ¿ no injury.
Additional Manufacturer Narrative
Both the peritoneal and ventricular catheter were returned in pieces.The peritoneal catheter was returned in three pieces measuring 36 cm, 17 cm, and 1 cm.The ventricular catheter was returned in three pieces measuring 4 cm, 13 cm, and 5 cm.It is unknown how or when the damage occurred.The returned segments were patent and passed leak testing when tested individually.The instructions for use (ifu) that accompany the device caution that ¿low tear strength is a characteristic of most unreinforced silicone elastomer materials.Care must be taken with the handling and placement of the silicone elastomer catheter tubing to avoid cuts, nicks or tears.¿ there was proteinaceous debris observed within the interior of the catheters.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: 7796898
• Report Number: 2021898-2018-00409
• Device Sequence Number: 2076177
• 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 Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2018

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: No Information
• Device Expiration Date: 06/01/2019
• Device Model Number: 95001
• Device Catalogue Number: 95001
• Device Lot Number: 0008900470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 09/20/2018
• 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: 59 YR
• Patient Weight: 78