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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. POD12; HCG, KRD
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PENUMBRA, INC. POD12; HCG, KRD Back to Search Results
Catalog Number RBYPOD12
Medical Device Problem Codes Bent (1059); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 05/23/2018
Type of Reportable Event Malfunction
Additional 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 or Problem Description
During preparation for a coil embolization procedure, the hospital technician inadvertently bent the pod12 as the pod12 was caught on the patient drape upon removal from the packaging.The damage to the pod12 was found prior to use and therefore, was not used in the procedure.The procedure was completed using a new pod12.
 
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Brand Name
POD12
Common Device Name
HCG, KRD
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
MDR Report Key7626529
Report Number3005168196-2018-01221
Device Sequence Number1898134
Product Code HCG
UDI-Device Identifier00814548019666
UDI-Public00814548019666
Combination Product (Y/N)N
Initial Reporter StateND
Initial Reporter CountryUS
PMA/510(K) Number
K173614
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/23/2018
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
Operator of Device Radiologic Technologist
Device Expiration Date03/04/2026
Device Catalogue NumberRBYPOD12
Device Lot NumberF82207
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/23/2018
Initial Report FDA Received Date06/21/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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