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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. ACCU-FLO* CSF RESV 14 MM; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

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CODMAN & SHURTLEFF, INC. ACCU-FLO* CSF RESV 14 MM; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Catalog Number 826100
Device Problem Obstruction of Flow (2423)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 01/14/2019
Event Type  Injury  
Manufacturer Narrative
Udi -- (b)(4).Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.A review of manufacturing records found no discrepancies when the device was released.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 a patient had an implantation of an intracerebral rickham ventriculostomy (icv) set (codman shurtleff generic icv device).It was noted that the patient experienced a grade 3 icv malfunction (device malfunction).Due to the malfunction, it was not possible to extract cerebrospinal fluid (csf), or to infuse saline.It was reported that the subject¿s catheter had initially been placed in the third ventricle.The catheter had worked for eight infusions; however, during the ninth infusion the reservoir had gone flat and the infusion team was unable to infuse normal saline or obtain a csf sample.The overseeing neurosurgeon decided that the device should be examined under anesthesia in the operating room.The subject was hospitalized and underwent surgery.The neurosurgeon didn¿t find and obstruction or kink in the catheter, but it still wasn¿t functioning either.After moving the catheter to the lateral ventricle, the surgeon was able to obtain a csf sample and infuse again without incidences.It was reported that the surgery went well and the patient was discharged from the hospital within 24 hours.The outcome of the event was updated by the investigator from not recovered/not resolved to recovered/resolved.The investigator reported that it was only the device associated wit the event and not the needle and listed as non-serious.The investigator assessed the event of device malfunction as related to the treatment with bmn 250.
 
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Type of Device
SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
rue girardet 29
le locle CH 24 00
SZ  CH 2400
Manufacturer (Section G)
CODMAN & SHURTLEFF, INC.
rue girardet 29
le locle CH 24 00
SZ   CH 2400
Manufacturer Contact
karen anigbo
11 cabot boulevard
mansfield, MA 02048
7819715608
MDR Report Key8340324
MDR Text Key136170625
Report Number1226348-2019-10101
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation Physician
Type of Report Initial
Report Date 01/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number826100
Device Lot Number119273
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/18/2019
Initial Date FDA Received02/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/22/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Age4 YR
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