MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. PROGRAMMABLE VALVE IN-LINE W/SIPHONGUARD; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-3832

Device Problem Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 03/28/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

V-p valve was found with precipitation , changed another one to complete.The patient is (b)(6), female and (b)(6).Preoperative ct showed the patient with ventricular dilatation.And the patient did ventriculoperitoneal shunt operation on (b)(6) 2017.Shunt tube was inserted into 5 cm, v-p shunt valve pressure was adjusted to 150 mm h2o.The ct ventricle was significantly expanded after operation, and there was no significant improvement in consciousness.Two days after operation, the pressure was adjusted to 120, and 4 days after operation, the pressure was adjusted to 100.There was no significant improvement in consciousness either.And then on (b)(6) 2017, the patient had ventriculoperitoneal shunt exploration operation, it found the v-p shunt valve had precipitate inside which is not clear.Changed another one to complete the second operation.The patient is still in the observation and patient¿s consciousness become a little better.

Manufacturer Narrative

(b)(4).Upon completion of the investigation, it was noted that the images were taken of the valve ¿as received¿ and are attached.The valve was visually inspected; some biological debris was noted at the base of the needle chamber.The position of the cam when valve was received was 100mmh2o.The valve was hydrated.The valve was tested for programming with programmer 82-3126 with serial number (b)(4), the valve passed the test.The valve was flushed, the valve passed the test no occlusion was noted.The valve was leak tested, no leaks noted.The valve was reflux tested.The valve passed the test.The siphon guard was tested.The valve passed the test.The valve was dried.The siphon guard was removed.The valve was then pressure tested, the valve passed the test.Review of the history device records confirmed the valve product code 82-3832, with lot cvdcpl, conformed to the specifications when released to stock on the 28th april 2016.Review of the history device records confirmed the bactiseal catheter product code 82-3072, with lot 1106466, conformed to the specifications when released to stock on the 9th january 2017.No root cause could be determined, as the problem reported by the customer could not be duplicated.If the bactiseal catheter is returned in the future the complaint will be reopened and the catheter investigated.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.

• Brand Name: PROGRAMMABLE VALVE IN-LINE W/SIPHONGUARD
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; le locle CH 24 00; SZ CH 2400
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6538051
• MDR Text Key: 74209007
• Report Number: 1226348-2017-10298
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992173
• 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 Expiration Date: 03/31/2021
• Device Catalogue Number: 82-3832
• Device Lot Number: CVDCPL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/10/2017
• Initial Date FDA Received: 05/02/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2016
• 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: 65 YR