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	12/19/2017
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 was blocked and cerebrospinal fluid could not flow smoothly.An explant of the catheter was planned for (b)(6) 2017.The patient's status was listed as alive - no injury.
Additional Manufacturer Narrative
The catheter was patent and returned in four pieces, measuring 92 cm, 11 cm, 5.5 cm, and 26.5.Proteinaceous debris was observed within the interior and exterior of the catheter.The device did not meet the requirements for leak testing due to multiple tears was observed throughout the catheter.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.¿ all catheters are 100% inspected at the time of manufacture.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Explant date updated.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Clarification of analysis results: the ventricular catheter was patent and returned in two pieces, measuring 11 cm, and 5.5 cm.Proteinaceous debris was observed within the interior and exterior of the catheter.The device did not meet the requirements for leak testing due to a tear observed approximately 5.5 cm from the proximal end.The peritoneal catheter was patent and returned in two pieces, measuring 92 cm, and 26.5 cm.Proteinaceous debris was observed within the interior and exterior of the catheter.The device did not meet the requirements for leak testing due to a tear observed approximately 26.5 cm from the proximal end.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.¿ 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: 7206348
• Report Number: 2021898-2018-00030
• Device Sequence Number: 16437414
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/12/2018

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: 09/26/2018
• Device Model Number: 95001
• Device Catalogue Number: 95001
• Device Lot Number: 0008552762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2017
• Supplement Date Received by Manufacturer: 01/30/2018; 03/26/2018; 04/11/2018
• Initial Report FDA Received Date: 01/19/2018
• Supplement Report FDA Received Date: 02/28/2018; 04/03/2018; 04/12/2018
• 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