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

Catalog Number RBYPOD8

Device Problems Unraveled Material (1664); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2022

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a coil embolization procedure in the portal vein using a pod coil and a non-penumbra microcatheter.During the procedure, the physician placed multiple coils in the target vessel using the microcatheter.Next, the physician advanced a pod coil into the target location; however, the pod coil was not forming to the physician¿s satisfaction.Therefore, the physician decided to remove the pod coil.While retracting, the physician experienced resistance and pulled the pod coil against resistance; consequently, the pod coil unraveled.The physician pulled and removed the majority of the pod coil that had unraveled; however, the remaining distal end of the unraveled pod coil was stuck and could not be removed.Therefore, the physician decided to cut the pod coil, leaving a thread in the portal vein.The physician was satisfied with the packing density and decided to end the procedure.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned pod8 confirmed that the embolization coil was unraveled, and the stretch resistant component was fractured.The unraveling coil was likely due to a stretch resistant component fracture.If the pod8 is forcefully retracted against resistance, damage such as this may occur.Evaluation revealed that the pod8 was returned inside a non-penumbra microcatheter, and both devices were inside a non-penumbra 4f sheath.Further evaluation revealed that the non-penumbra 4f sheath was kinked in multiple locations, and the pod8 and non-penumbra microcatheter were unable to be removed from the 4f sheath.This damage may have contributed to resistance while retracting the pod8 during the procedure.The root cause could not be determined.Further evaluation also revealed the pod8 and non-penumbra microcatheter had kinks throughout their lengths.This damage was likely incidental to the complaint.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: POD
• Type of Device: 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: 14220178
• MDR Text Key: 291390061
• Report Number: 3005168196-2022-00193
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548019635
• UDI-Public: 814548019635
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBYPOD8
• Device Lot Number: F111447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1