MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. CERTAS INLINE VLV W/UNTZD CAT; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-8802

Device Problem Kinked (1339)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

(b)(4).It is not clear at this point if the device and/or lot information is available.Without the device and/or lot information it is not possible for codman to conduct a proper investigation.If the device is returned the complaint will be investigated and a follow up report will be filed.If lot information does becomes available and if the record review indicates that there was a non-conformity a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.Device not available.

Event Description

The valve was implanted to the patient via lp-shunt for inph.Just after the surgery, although gait disorder was improved, the kink of the catheter was confirmed when examined due to gait disorder deterioration.On (b)(6) 2017: the surgery was performed for replacement of the catheter.Even it was improved one, the patient complained a stomach ache on (b)(6), and he came to the site.The infection was suspected and the surgery was performed on (b)(6).The cell number was about 300-400.He was follow-up without shunting but he wanted the shunting because walking will be improved.On (b)(6) 2017: the revision surgery was performed via vp shuntwith the valve (82-8802).On (b)(6) 2017: he was discharged with good progress in walking improvement consideration1: the number of cells already had 300-400 when revising the catheter on (b)(6), so it might have been infected at this time.It may be that csf stagnated due to kink and the number of cells increased consideration2: because the size of the valve was larger than chpv, it may be considered as one factor that the shape was more infectious than chpv.(this site uses micro a valve 82-3112 for lp shunt, especially the difference in size compared with certas was obvious) (b)(6).

Manufacturer Narrative

Three potential lot numbers were provided: cvccnj, 122310, 130588.While we were not able to identify the specific lot involved in this event, review of the provided three numbers found there were no discrepancies in any of these lots prior to distribution of the devices.If additional relevant information becomes available, a follow-up report will be submitted.At present, we consider this complaint to be closed.

• Brand Name: CERTAS INLINE VLV W/UNTZD CAT
• 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: 7169360
• MDR Text Key: 96585448
• Report Number: 1226348-2018-10029
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112156
• 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

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 82-8802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2018
• 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): Required Intervention