MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY VENTRICLEAR¿ II VENTRICULAR DRAINAGE CATHETER SET WITH COOK SPECTRUM® ANTIBIOTIC; CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC OR ANTIMICROBIAL AGENTS)

Catalog Number N-VVDC-01-ABRM

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

The product was unavailable for return.Therefore, an evaluation of the device performance was not possible.

Event Description

It was reported to medtronic neurosurgery that a catheter broke off during removal.According to the report, the remaining portion of the catheter is inside the patient's cranium.

Manufacturer Narrative

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

• Brand Name: VENTRICLEAR¿ II VENTRICULAR DRAINAGE CATHETER SET WITH COOK SPECTRUM® ANTIBIOTIC
• Type of Device: CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC OR ANTIMICROBIAL AGENTS)
• 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: 6042302
• MDR Text Key: 57916685
• Report Number: 2021898-2016-00375
• Device Sequence Number: 1
• Product Code: NHC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/19/2016

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2014
• Device Catalogue Number: N-VVDC-01-ABRM
• Device Lot Number: G32429
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/19/2016
• Initial Date FDA Received: 10/19/2016
• Supplement Dates Manufacturer Received: 09/19/2016
• Supplement Dates FDA Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/09/2011
• 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; Required Intervention