MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR HERMETIC LARGE STYLE VENTRICULAR CATHETER SET; N/A

Catalog Number INS4500

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

Patient Problem Fistula (1862)

Event Type  Injury  

Manufacturer Narrative

The reported device was not returned for evaluation.Based on the absence of lot and catalog number used in the retrospective study published on 2013, it is not possible to perform the dhr review and neither to identify the manufacturing time frame for the histories review.The reported condition is unconfirmed.The evaluation of the complaint unit is required to determine a potential root cause of the reported condition.The root cause is undetermined.Doi: 10.1227/neu.0b013e318279e783.Linked to mfg report numbers: 2648988-2018-00083; 2648988-2018-00084; 2648988-2018-00085; 2648988-2018-00086; 2648988-2018-00088; 2648988-2018-00089; 2648988-2018-00090.

Event Description

This is 3 out of 8 reports.Operative neurosurgery (2013) published "iatrogenic vascular complications associated with external ventricular drain placement: a report of 8 cases and review of the literature" in which described 9 cases of evd-related vascular trauma: arteriovenous fistulas and 2 traumatic aneurysms.This study includes patients who were treated in the neuro critical care unit at a university affiliated level i trauma center and children¿s hospital during a 3-year period.Patients included in this study had placement of an evd and an angiographically confirmed vascular lesion associated with the evd.During a 3 year period, 299 evds were placed.An integra large-style ventricular catheter (3mm outer diameter) was passed through the craniostomy into the frontal horn of the lateral ventricle.The trajectory of the catheter in the coronal plane was the medial canthus of the ipsilateral eye and the external auditory canal in the sagittal plane.Catheters were not inserted deeper than 7 cm at the bone edge.Once clear cerebrospinal fluid was visualized, the metal stylet was removed and the catheters were tunneled subcutaneously approximately 2 to 3 cm away form the incision.The incision was closed with nylon suture and the ventricular catheter was connected to the drainage system in a sterile manner ad secured to the patient.A head ct was performed after the procedure to verify catheter position.Eight patients (2.75%), 3 male and 5 female (mean age, 48 +/- 20 years), developed vascular lesions associated with evds.Six patients developed arteriovenous fistulas and 2 patients developed a traumatic aneurysm.Patient 3: a (b)(6) year old female had an admitting diagnosis of subarachnoid hemorrhage.The patient developed a dural arteriovenous fistula (avf).The arterial feeder of the superficial draining fistula arose from the right middle meningeal artery (mma).The fistula was treated with transarterial embolization.Conclusion: the data suggest that iatrogenic vascular trauma associated with evd insertions (2.75%) may be more common than is currently appreciated.Endovascular treatment is effective and may be necessary when these lesions do not resolve spontaneously.

• Brand Name: HERMETIC LARGE STYLE VENTRICULAR CATHETER SET
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; road 402 north, km 1.2; anasco PR 00610
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR 00610
• Manufacturer Contact: kimberly shelly ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 8228949
• MDR Text Key: 132561426
• Report Number: 2648988-2018-00087
• Device Sequence Number: 1
• Product Code: HCD
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: INS4500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 55 YR