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U.S. Department of Health and Human Services

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

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PENUMBRA, INC. POD PACKING COIL; HCG, KRD Back to Search Results
Catalog Number RBYPODJ60
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/07/2018
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.The hospital discarded the device.
 
Event Description
The patient was undergoing a coil embolization procedure in the ovarian vein using pod packing coils (podjs).During the procedure, the physician successfully placed a ruby coil using a non-penumbra microcatheter.The physician then attempted to place a podj, however, the podj unintentionally detached before the physician advanced it out of the microcatheter.The physician therefore removed the microcatheter with the podj inside, and the procedure was completed using additional coils and the same microcatheter.There was no report of an adverse effect to the patient.
 
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Brand Name
POD PACKING 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 Key7664373
MDR Text Key113283850
Report Number3005168196-2018-01342
Device Sequence Number1
Product Code HCG
UDI-Device Identifier00814548017679
UDI-Public00814548017679
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170852
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial
Report Date 06/07/2018
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 Physician
Device Catalogue NumberRBYPODJ60
Device Lot NumberF81878
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/07/2018
Initial Date FDA Received07/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/13/2018
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 Age44 YR
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