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

Catalog Number	93092
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Scarring (2061); Reaction (2414)
Date of Event	10/31/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Approximately 53 cm of the ares catheter was returned.The catheter was patent and passed leak testing.There was proteinaceous debris observed on the exterior of the catheter.A review of the manufacturing and sterilization records showed no anomalies.All catheters are 100% inspected at the time of manufacture.
Event or Problem Description
It was reported to medtronic neurosurgery the patient experienced a reaction with the peritoneal catheter.The entire system was removed.Upon explant, it was stated that there was scarring and diverse adhesions at the distal end of the peritoneal catheter that inserted into the belly.There was no reaction from the valve connection to where the peritoneal catheter entered the belly.Loculations around the liver and inflammatory tissue around the area was also noted.Reportedly, the doctor was going to allergic testing and it might have been because of the antibiotics the patient was allergic to.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ARES ANTIBIOTIC-IMPREGNATED PERITONEAL CATHETER
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6142356
• Report Number: 9612164-2016-01215
• Device Sequence Number: 153385
• Product Code: JXG
• UDI-Device Identifier: 00643169762657
• UDI-Public: 00643169762657
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K110560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2016

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?: No
• Operator of Device: No Information
• Device Expiration Date: 03/04/2017
• Device Catalogue Number: 93092
• Device Lot Number: 0007715596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2016
• Initial Date Received by Manufacturer: 11/02/2016
• Supplement Date Received by Manufacturer: 11/02/2016
• Initial Report FDA Received Date: 12/02/2016
• Supplement Report FDA Received Date: 09/27/2017
• 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: 13 YR
• Patient Weight: 53