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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 RBYPODJ30
Device Problems Break (1069); Inadequacy of Device Shape and/or Size (1583); Premature Separation (4045)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/29/2018
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 manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report numbers: 3005168196-2018-01896; 3005168196-2018-01897.
 
Event Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using pod4s and pod packing coils (podjs).During the procedure, a pod4 was not forming properly in the target location and, therefore, the pod4 was removed.The physician then successfully deployed and detached a ruby coil in the target location using the same lantern delivery microcatheter (lantern).Next, the physician attempted to place a podj; however, while advancing the podj into the target location, the lantern kicked out of place.The podj was therefore removed and the physician adjusted the lantern and attempted to place another podj.However, the podj was the wrong size.While retracting to remove the podj, it unintentionally detached.The physician attempted to remove the detached podj using a snare device; however, the podj broke.The physician was able to remove part of the embolization coil, and the other part was left in the patient¿s hepatic artery.The procedure ended at this point.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
MDR Report Key7906747
MDR Text Key121638788
Report Number3005168196-2018-01898
Device Sequence Number1
Product Code HCG
UDI-Device Identifier00814548017655
UDI-Public00814548017655
Combination Product (y/n)Y
PMA/PMN Number
K170852
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/01/2005,08/29/2018
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 Health Professional
Device Catalogue NumberRBYPODJ30
Device Lot NumberF81927
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Initial Date Manufacturer Received 08/29/2018
Initial Date FDA Received09/25/2018
Supplement Dates Manufacturer Received01/14/2005
Supplement Dates FDA Received06/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age67 YR
Patient Weight98
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