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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY VENTRICLEAR II VENTRICULAR DRAINAGE CATHETER SET WITH COOK SPECTRUM ANTIBIOTIC CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC OR ANTIMICROBIAL AGENTS)

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MEDTRONIC NEUROSURGERY VENTRICLEAR II VENTRICULAR DRAINAGE CATHETER SET WITH COOK SPECTRUM ANTIBIOTIC CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC OR ANTIMICROBIAL AGENTS) Back to Search Results
Catalog Number 50318
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Date 03/17/2017
Event Type  Injury  
Manufacturer Narrative
The product was unavailable for return as it was discarded at the facility. Therefore an evaluation of the device performance was not possible. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported to medtronic neurosurgery that a physician stated the catheter broke off during a procedure during insertion. According to the report, the catheter popped off/snapped while in the patient during the procedure. Reportedly, the patient experienced pneumocephalus. Per the surgeon, the current status of the patient was fine and they had returned to baseline.
 
Manufacturer Narrative
Additional information received reported that due to the catheter breaking, the surgeon was delayed in relieving the intracranial pressure of the brain and the patient developed pneumocephalus. According to the report, a different manufacturer¿s catheter was used. It was noted that some breakage happened after the catheter had been sutured in the ventricles of the patient¿s brain.
 
Manufacturer Narrative
Additional information received reported that no unintended section of the catheter remained inside of the patient's body and no additional procedures were required due to the reported event. This reported event is 1 of 3 similar events. Please refer to manufacturer reports #2021898-2017-00222 and #2021898-2017-00223 for details regarding the other two events. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameVENTRICLEAR II VENTRICULAR DRAINAGE CATHETER SET WITH COOK SPECTRUM ANTIBIOTIC
Type of DeviceCATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC OR ANTIMICROBIAL AGENTS)
Manufacturer (Section D)
MEDTRONIC NEUROSURGERY
125 cremona drive
goleta CA 93117
Manufacturer (Section G)
MEDTRONIC NEUROSURGERY
125 cremona drive
goleta CA 93117
Manufacturer Contact
stacy ruemping
7000 central avenue ne rcw215
minneapolis,mn, CA 55432
7635260594
MDR Report Key6514826
MDR Text Key73453919
Report Number2021898-2017-00224
Device Sequence Number1
Product Code NHC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071640
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 03/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/18/2018
Device Catalogue Number50318
Device Lot Number7025160
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/22/2017
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/22/2017 Patient Sequence Number: 1
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