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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 RBYPODJ45
Medical Device Problem Codes Failure to Fold (1255); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/01/2018
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
The patient was undergoing a coil embolization procedure to treat a varicocele using a pod packing coil (podj).During the procedure, while attempting to deploy a podj into the target vessel, the podj and did not take its intended shape; therefore, it was removed and the procedure was ended.There was no report of an adverse effect to the patient.
 
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Brand Name
POD PACKING COIL
Common Device Name
HCG, KRD
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
MDR Report Key7385257
Report Number3005168196-2018-00663
Device Sequence Number1031014
Product Code HCG
UDI-Device Identifier00814548016726
UDI-Public00814548016726
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K170852
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/02/2018
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 Physician
Device Expiration Date10/30/2025
Device Catalogue NumberRBYPODJ45
Device Lot NumberF80313
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/02/2018
Initial Report FDA Received Date03/30/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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