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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR BACTISEAL VENTRICULAR CATHETER

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INTEGRA LIFESCIENCES SWITZERLAND SAR BACTISEAL VENTRICULAR CATHETER Back to Search Results
Catalog Number 823073
Device Problem Infusion or Flow Problem (2964)
Patient Problem Failure of Implant (1924)
Event Date 06/16/2021
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
2 of 3 reports. Other mfg report numbers: 3013886523-2021-00286 and 3013886523-2021-00288. A facility reported a codman hakim programmable valve and catheters (823073 and 823074) were implanted into a (b)(6) old patient on (b)(6) 2021 with removal of the device occurring 30 minutes later. The physician found that there was no cerebral spinal fluid flowing out from the abdominal catheter. The physician disconnected the abdominal catheter with the valve and there was no cerebral spinal fluid flowing out from the valve. Due to the patients age, the physician retrieved the hakim valve and catheters and changed with the device of another company to complete the procedure and limit the anesthesia time. A 30-minute surgical delay was reported due to the shunt adverse event. The patient is stable.
 
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Brand NameBACTISEAL VENTRICULAR CATHETER
Type of DeviceBACTISEAL VENTRICULAR CATHETER
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 Key12125243
MDR Text Key264475910
Report Number3013886523-2021-00287
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2021
Device Catalogue Number823073
Device Lot Number5262555
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/16/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/20/2021
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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