MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN LUMBER CATHETER KIT; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-1707

Device Problem Kinked (1339)

Patient Problem No Information (3190)

Event Date 02/02/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Upon completion of the investigation a follow up report will be filed.

Event Description

A cretas valve (the article number is unk) was implanted to the patient with lp-shunt (initial setting were unk) on (b)(6) 2017.However, the surgeon noticed the size of the ventricle was not improved, so a shunt contrast examination was performed on (b)(6) 2017.As the result, the surgeon suspected there was a kink at the connection of the lumbar vertebra catheter side, and also noticed that the pressure setting was unable to be adjusted.The valve was explanted from the patient and revised by the reported ns9008 on (b)(6) 2017.The explanted certas valve was discarded already.The ventricular enlargement was still not improved even though the pressure was adjusted to 30 mmh2o on (b)(6) 2017.The abdominal catheter was pulled outside of the body on (b)(6) 2017 for drainage.Finally, the valve was explanted from the patient and revised by an alternative valve (82-3100) with vp-shunt (the initial setting was 30mmh2o) on (b)(6) 2017.After the shunt revision, the ventricular size was slightly improved and the conscious state is good so far.The patient is a (b)(6) female and (b)(6).The original disease was sah.No further information was provided by the hospital.

Manufacturer Narrative

It has been communicated that the device and/or lot information is not available for evaluation.Without the device and/or lot information it is not possible for codman to conduct a proper investigation.If at some point the device and/or lot information does become available, this complaint will be re-opened, evaluated and a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time this complaint is considered closed.Device not available.

• Brand Name: CODMAN LUMBER CATHETER KIT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6383837
• MDR Text Key: 69256209
• Report Number: 1226348-2017-10146
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964923
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 82-1707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/17/2017
• Initial Date FDA Received: 03/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/23/2017
• 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
• Treatment: CERTAS VALVE; NS-9008
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR