MAUDE Adverse Event Report: UNK BAC CATH; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number UNK BAC CATH

Device Problem Migration or Expulsion of Device (1395)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 10/12/2015

Event Type  Injury  

Manufacturer Narrative

Upon completion of the investigation a follow up report will be filed.

Event Description

In the literature article "intracardiac migration and knotting of a ventriculoperitoneal shunt" published journal of clinical neuroscience 22 (2015) 771-773, it was reported that a (b)(6) year-old female had catheter displacement and migration of the unknown bactiseal peritoneal catheter after implantation with return of the nph (normal pressure hydrocephalus) symptoms.Per the article: "a (b)(6)-year-old woman underwent an unremarkable vp shunt insertion (codman hakim programmable valve with codman bactiseal ventricular and distal catheter; codman & shurtleff, (b)(4), usa) for normal pressure hydrocephalus (nph) in early (b)(6) 2013 with initial improvement in her symptoms.Postoperative imaging, including a radiograph shunt series, confirmed correct shunt placement.Two months later she returned with unrelated poorly controlled hypertension and a return of gait unsteadiness suggesting shunt malfunction with recurrence of symptoms of nph.A chest radiograph indicated that the shunt had migrated from the abdomen into the chest and was overlying the cardiac shadow.A ct scan demonstrated that the shunt entered the right internal jugular vein (ijv) above the right clavicle with multiple coils in the right atrium.There was no shunt identified in the abdomen.Revision of the vp shunt was planned between the neurosurgery and vascular surgery units." it was reported that a surgical removal was successful and a new bactiseal peritoneal catheter was successfully implanted with resolution of the symptomology.At the time of complaint entry no device specific information, i.E.Catalogue/lot number, is available.

• Brand Name: UNK BAC CATH
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 5554200
• MDR Text Key: 42064498
• Report Number: 1226348-2016-10273
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK BAC CATH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR