MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY PERITONEAL CATHETER WITH BIOGLIDE, STANDARD, 90 CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	93522
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fever (1858)
Date of Event	04/07/2019
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
Information was received regarding a patient undergoing cerebral peritoneal shunt surgery due to traumatic brain injury.It was reported that the patient had a continuous fever that occurred one week after surgery and did not improve.As there was a risk of infection, the device was removed.After the patient returned to normal another surgery was completed.There was no product damage.There were no related patient symptoms.Additional information received reported that no adjustment was done anytime after implantation.No activities/analyses were done on the valve after the removal from the patient prior to sending it to the manufacturer.The valve was not bathed in any chemicals or antibiotics prior to implantation.No mri's were performed while the device was implanted.
Additional Manufacturer Narrative
The returned catheter met the requirements for patency and leak testing.32.5 inches of the catheter was returned.Proteinaceous debris was observed on the interior and exterior of the catheter.The instructions for use cautions, ¿shunt obstruction may occur in any of the components of the shunt system.The catheter may become internally occluded due to tissue fragments, blood clots, tumor cell aggregates, bacterial colonization, pseudocyst, or other debris.¿ due to the amount proteinaceous debris within the catheter, tensile testing was not performed.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, STANDARD, 90 CM
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8562480
• Report Number: 2021898-2019-00168
• Device Sequence Number: 1587094
• Product Code: JXG
• UDI-Device Identifier: 00643169466005
• UDI-Public: 00643169466005
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K792005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2019

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: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 93522
• Device Catalogue Number: 93522
• Device Lot Number: E14222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 06/28/2019
• 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