MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY PERITONEAL CATHETER WITH BIOGLIDE AND 8 SLITS; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	27536
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Therapeutic Effects, Unexpected (2099)
Date of Event	03/06/2018
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 that after the procedure was completed, no change in intracranial pressure was observed.The device was replaced by another device.
Additional Manufacturer Narrative
Implant, explant, and event dates updated.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The peritoneal catheter was returned and was patent.However, the returned catheter did not meet the requirements for leak testing because it was returned in two pieces, one measuring 65 cm, and one measuring 18 cm, a total of 83 cm.It is unknown how or when this damage occurred.The edges around the tear were jagged.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.¿ proteinaceous debris was observed within the interior and exterior of the catheter.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: PERITONEAL CATHETER WITH BIOGLIDE AND 8 SLITS
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7338965
• Report Number: 2021898-2018-00141
• Device Sequence Number: 1228244
• Product Code: JXG
• UDI-Device Identifier: 00643169472808
• UDI-Public: 00643169472808
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K951258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2018

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: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 27536
• Device Catalogue Number: 27536
• Device Lot Number: E27296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2018
• Supplement Date Received by Manufacturer: 03/15/2018; 04/06/2018
• Initial Report FDA Received Date: 03/14/2018
• Supplement Report FDA Received Date: 03/22/2018; 04/10/2018
• 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