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

Catalog Number RBYPODJ45

Device Problem Break (1069)

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

Event Date 05/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.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 varices using pod packing coils (pod pc), ruby coil, ruby coil detachment handle (handle), a lantern delivery microcatheter (lantern), a non-penumbra diagnostic catheter, and non-penumbra coils.During the procedure, the physician placed one ruby coil and two pod pcs in the target vessel using the lantern.The physician then advanced another pod pc into the vessel and detached it using the handle.However, while removing the pusher assembly of the pod pc, the physician noticed only part of the pusher assembly was removed.The physician proceeded to advance non-penumbra coils into the target location; however, the coils would not advance out from the lantern.The physician removed the lantern and flushed it on the back table but was not able to locate the non-penumbra coils.The physician then removed the diagnostic catheter and upon flushing it, the broken pusher assembly of the pod pc and other coils were removed from the catheter.The procedure was completed using a new pod pc and non-penumbra coils with the same handle, lantern, and diagnostic catheter.There was no adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned pod pc confirmed that the pusher assembly was fractured and revealed kinks at the fractured locations.If the pusher assembly is manipulated against resistance during use, damage such as a kink and subsequent fracture may occur.Further evaluation revealed multiple kinks on the fractured segments.This damage was incidental to the reported complaint and the root cause could not be determined.Penumbra coils are visually 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.

Manufacturer Narrative

Please note that this complaint was submitted to the fda by the user facility with the following reference number: (b)(4) the following sections are being updated based on additional information included in the user facility report submitted to the fda: 1.Section g.Box 3.Report source h3 other text : placeholder.

• Brand Name: POD PACKING COIL
• 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 ; 510748-320
• MDR Report Key: 17035187
• MDR Text Key: 316472227
• Report Number: 3005168196-2023-00254
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548017662
• UDI-Public: 814548017662
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBYPODJ45
• Device Lot Number: F00004554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2023
• 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: 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2022
• 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
• Patient Age: 71 YR
• Patient Sex: Male