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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SMART COIL; HCG, KRD

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PENUMBRA, INC. PENUMBRA SMART COIL; HCG, KRD Back to Search Results
Model Number 400SMTHXSFT0103
Device Problems Device Dislodged or Dislocated (2923); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/10/2021
Event Type  malfunction  
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 manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
 
Event Description
The patient was undergoing a coil embolization procedure in the supraclinoid segment of the left internal carotid artery (ica) using penumbra smart coils (smart coil) and a non-penumbra microcatheter.During the procedure, the physician successfully placed two smart coils in the target vessel using the microcatheter.While advancing the next smart coil into the aneurysm using the microcatheter, the physician experienced resistance and the tip of the microcatheter kicked out.Subsequently, the smart coil was pulled back into the parent vessel; therefore, the smart coil was removed intact.It was reported that the presence of a stent made it difficult to reintroduce the microcatheter back into the aneurysm sac.The procedure ended at this point.There was no report of an adverse effect to the patient.
 
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Brand Name
PENUMBRA SMART COIL
Type of Device
HCG, KRD
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer Contact
veronica farris
one penumbra place
alameda, CA 94502
5107483200
MDR Report Key12144407
MDR Text Key261022017
Report Number3005168196-2021-01510
Device Sequence Number1
Product Code HCG
UDI-Device Identifier00814548015620
UDI-Public00814548015620
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K160832
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 01/01/2005,07/09/2021
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 Expiration Date08/23/2022
Device Model Number400SMTHXSFT0103
Device Catalogue Number400SMTHXSFT0103
Device Lot NumberF78836
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Initial Date Manufacturer Received 06/11/2021
Initial Date FDA Received07/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/24/2017
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 Age69 YR
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