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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE REPERFUSION CATHETER; NRY

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PENUMBRA, INC. PENUMBRA SYSTEM ACE REPERFUSION CATHETER; NRY Back to Search Results
Device Problems Break (1069); Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/25/2018
Event Type  Injury  
Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.The hospital discarded the device.
 
Event Description
The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica) using an ace catheter.During the procedure, the physician advanced a filter wire into the patient¿s ica, and then advanced the ace catheter past the filter wire, using a neuron max 6f 088 long sheath (neuron max).While in the patient, the radiopaque marker on the ace catheter broke off and was floating in the middle cerebral artery (mca).The physician therefore removed the radiopaque marker using a non-penumbra stent retriever.There was no report of an adverse effect to the patient.
 
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Brand Name
PENUMBRA SYSTEM ACE REPERFUSION CATHETER
Type of Device
NRY
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer Contact
veronica farris
one penumbra place
alameda, CA 94502
5107483200
MDR Report Key7553707
MDR Text Key109544707
Report Number3005168196-2018-01075
Device Sequence Number1
Product Code NRY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 05/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Physician
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/01/2018
Initial Date FDA Received05/30/2018
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 Number1
Patient Outcome(s) Required Intervention;
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