MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY UNKNOWN CATHETER; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number UNKNOWN-C

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Hemorrhage, Subarachnoid (1893); Hemorrhage, Subdural (1894)

Event Date 01/10/2014

Event Type  Injury  

Manufacturer Narrative

These events were identified during review of scientific literature.The article contained only limited and non-specific device information.Contact with the corresponding author has been unsuccessful in yielding additional device information.The event reported in the source literature could not be matched to information previously reported to medtronic neurosurgery.The products were unavailable for return.Therefore an evaluation of device performance was not possible.A review of the manufacturing records was not possible as no lot numbers were provided.All catheters are 100% inspected at the time of manufacture.Literature article: hemorrhagic complications of ventriculostomy: incidence and predictors in patients with intracerebral hemorrhage authors: eric s.Sussman, b.S., christopher p.Kellner, m.D., eric nelson, b.A., michael m.Mcdowell, b.S., samuel s.Bruce, m.A., rachel a.Bruce, b.A., zong zhuang, b.S., and e.Sander connolly jr., m.D.J neurosurg 120:931¿936, 2014.Http://thejns.Org/doi/abs/10.3171/2013.12.Jns131685.

Event Description

Medtronic neurosurgery identified the following information upon review of scientific literature: a total of 22 patients experienced post ventriculostomy hemorrhage.The article noted that intraparenchymal hemorrhage occurred in 19 of these 22 patients, subarachnoid hemorrhage in 3, subdural hemorrhage in 1 and epidural hemorrhage in 1.Reportedly, 1 patient experienced simultaneous intraparenchymal and subdural hemorrhages, and 1 patient had both intraparenchymal and subarachnoid hemorrhages.The article stated that the majority of these bleeds were small and subclinical.The article also stated that post ventriculostomy hemorrhage was clinically significant in only 1 patient; the location of the bleed in this patient was epidural.According to the article, patients treated with smaller-diameter catheters had a significantly greater mean hemorrhage volume than patients treated with larger-diameter catheters.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN CATHETER
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: bob shokoohi ; 125 cremona drive; goleta, CA 93117 ; 8055718725
• MDR Report Key: 6030716
• MDR Text Key: 57483618
• Report Number: 2021898-2016-00371
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNKNOWN-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR