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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CODMAN BACTISEAL CATHETER KIT

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INTEGRA LIFESCIENCES SWITZERLAND SAR CODMAN BACTISEAL CATHETER KIT Back to Search Results
Catalog Number 823072
Device Problem Obstruction of Flow (2423)
Patient Problems Failure of Implant (1924); Cerebral Ventriculomeglia (2133)
Event Type  Injury  
Manufacturer Narrative
An investigation has been initiated based on the reported information. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
1 of 2 reports. Other mfg report number: 3013886523-2021-00299. A physician reported a hakim programmable in-line valve was implanted in a patient via ventricular peritoneal shunt on (b)(6) 2021 with an unknown initial setting. The valve was used with catheter 823072 (serial; unknown). The patient¿s condition was reported as stable one week after the operation. Ventricular enlargement was observed radiographically on (b)(6) 2021. No improvement in the ventricular enlargement was seen after changing the shunt valve pressure. There were not clinical symptoms of hydrocephalus other than the ventricular enlargement. The shunt was diagnosed as clogged by pumping. The patient was taken to the operating room for a shunt and catheter revision surgery on (b)(6) 2021. The patient is in ¿good condition. ¿ no further information was provided by the hospital.
 
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Brand NameCODMAN BACTISEAL CATHETER KIT
Type of DeviceBACTISEAL CATHETER KIT
Manufacturer (Section D)
INTEGRA LIFESCIENCES SWITZERLAND SAR
rue girardet 29
rue girardet 29
le locle
SZ
Manufacturer (Section G)
INTEGRA LIFESCIENCES SWITZERLAND SAR
rue girardet 29
ch-2400
le locle
SZ
Manufacturer Contact
vivian nelson
1100 campus drive
princeton, NJ 
6099362319
MDR Report Key12148178
MDR Text Key267668984
Report Number3013886523-2021-00300
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K102589
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number823072
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/04/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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