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

Catalog Number	RBYPOD12
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2023
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.This report is associated with mfr report number: 3005168196-2023-00138.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right internal iliac artery (iia) using pod coils, a pod packing coil (podj), a lantern delivery microcatheter (lantern), a non-penumbra 5f catheter, a non-penumbra 8f sheath, a non-penumbra 16f sheath and guidewire.It was noted that the patient''s anatomy was tortuous with extreme angulation.During the procedure, the physician advanced the 16f sheath over the guidewire in the patient and used it to make the left common iliac artery straight.The physician then advanced the 5f catheter over the lantern through the 8f sheath into the target location.Next, while advancing a pod coil through the lantern the physician experienced resistance and the pod coil became stuck at the proximal end of the lantern.Subsequently, the nurse accidently touched the proximal end of the pusher assembly of the pod coil and the pod coil unintentionally detached within the lantern.Therefore, the lantern containing the detached pod coil was removed.Afterwards, while re-advancing the lantern through the distal end of the 16f sheath and crossing over the target vessel, the physician experienced resistance and kinked the mid-shaft of the lantern.While advancing the next pod coil through the lantern, the physician experienced resistance and the pod coil became stuck at the kinked location of the lantern.Subsequently, the pod coil unintentionally detached within the distal end of the lantern.Therefore, the lantern containing the detached pod coil was removed.Next, the physician then successfully implanted a ruby coil in the target vessel using a new lantern.After that, the physician advanced a podj in the target vessel; however, the physician noticed that the podj was too long and that part of the podj was outside the target vessel.Therefore, the podj was removed.The procedure was completed with a stent graft, the same 16f sheath, the same 8f sheath, the same 5f catheter, and the same second lantern.There was no report of an adverse effect to the patient.

• Brand Name: POD
• Common Device Name: 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 Key: 16623931
• Report Number: 3005168196-2023-00139
• Device Sequence Number: 5334153
• Product Code: HCG
• UDI-Device Identifier: 00814548019666
• UDI-Public: 814548019666
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2023
• 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: RBYPOD12
• Device Lot Number: F00000249
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005