MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC.

Catalog Number UNK VALVE

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 11/13/2018

Event Type  Injury  

Manufacturer Narrative

Udi -- unknown part number, attempts to obtain product were unsuccessful, udi unavailable.Multiple attempts to obtain additional information were not successful.Complaint sample was not returned to codman and no lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

Event Description

It was reported from biomarin, that after implant of a codman rickham device, there was an unknown malfunction and the device was revised.The patient had an implantation of an intracerebral rickham ventriculostomy (icv) set (codman shurtleff generic icv device).The subject had his bmn 250 administration; however, during the administration of bmn 250, extravasation of study drug was observed and only 15 milligrams of bmn 250 was administered.The lot number and model number were not reported.The device was unable to be removed for an unreported reason and a new rickham icv device was implanted into the other lateral ventricle.The reporter assessed the event of device malfunction as related to the icv device.No other etiological factors were suspected.Additional information has been requested and, if received, the report will be updated.

• Brand Name: NI
• Type of Device: NI
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: karen anigbo ; 11 cabot boulevard; mansfield, MA 02048 ; 7819715608
• MDR Report Key: 8159513
• MDR Text Key: 130178452
• Report Number: 1226348-2018-10875
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2018
• 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): Other
• Patient Age: 6 YR
• Patient Weight: 29