MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY INNERVISION VENTRICULAR CATHETER, WITHOUT BIOGLIDE, BARIUM IMPREGNATED; CATHETER, VENTRICULAR

Catalog Number	27240
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930)
Date of Event	10/04/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information received reported the patient had developed a recurrent fever about a week after the placement of the external ventricular drain in the operating room.After the cerebrospinal fluid culture revealed the mycobacterium abscessus, the external ventricular drain (evd) was removed and replaced with a new evd catheter.After the replacement, the patient remained clinically stable, with no evidence of systemic infection and no new fevers.It was stated that all cultures remained negative after replacing the evd catheter.Reportedly, the hospital¿s investigation did not identify any environmental source of the infection.The patient had a medical history of bilateral intraventricular hemorrhage and hydrocephalus.According to the reported information, the external drainage system was the manufacturer¿s product and the evd catheter was a different manufacturer¿s product.Additional information received reported that a small catheter was used.This connected to a straight connector which then attached to a regular evd catheter with the tip cut off.This event had been previously reported under manufacturer report number 2021898-2016-00470.The product was unavailable for return.Therefore an evaluation of the device performance was not possible.A review of the manufacturing records showed no anomalies.All catheters are 100% inspected at the time of manufacture.
Event or Problem Description
It was reported to medtronic neurosurgery that the patient developed an infection after the placement of the device on (b)(6) 2016.According to the report, the patient found to have mycobacterium chelonae-abscessus group growing in culture from cerebrospinal fluid.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: INNERVISION VENTRICULAR CATHETER, WITHOUT BIOGLIDE, BARIUM IMPREGNATED
• Common Device Name: CATHETER, VENTRICULAR
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6532063
• Report Number: 2021898-2017-00244
• Device Sequence Number: 16360432
• Product Code: HCA
• UDI-Device Identifier: 00643169472723
• UDI-Public: 00643169472723
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K983331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2017

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: 02/28/2021
• Device Catalogue Number: 27240
• Device Lot Number: E11632
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2017
• Supplement Date Received by Manufacturer: 03/29/2017
• Initial Report FDA Received Date: 04/28/2017
• Supplement Report FDA Received Date: 10/03/2017
• 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: Required Intervention
• Patient Age: 18 MO
• Patient Weight: 9