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

Catalog Number	RBYPODJ45
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2019
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a type ii endoleak using a lantern delivery microcatheter (lantern) and pod packing coils (podjs).During the procedure, while attempting to advance a podj through the lantern with direct puncture, the lantern was kicked out due to the needle access being too close in proximity to the endograft.Subsequently, the physician decided to retract the podj.While retracting the podj through the lantern, the physician experienced resistance; therefore, the lantern containing the podj was removed.Upon removal, the lantern appeared kinked.The procedure was completed using a new lantern and podj.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the initial mfr report and is being included on this follow-up #01 mfr report: 3005168196-2019-02001.This report is associated with mfr report number: 3005168196-2019-02002.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #02 mfr report:3005168196-2019-02001.1.Section d.Box 4.Expiration date this report is associated with mfr report number: 1.3005168196-2019-02002 h3 other text : placeholder.

• Brand Name: POD PACKING COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9253914
• Report Number: 3005168196-2019-02001
• Device Sequence Number: 16756502
• Product Code: HCG
• UDI-Device Identifier: 00814548016726
• UDI-Public: 00814548016726
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K141134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2019
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Catalogue Number: RBYPODJ45
• Device Lot Number: F90130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 01/14/2005; 01/14/2005
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 10/31/2019; 12/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005