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

Catalog Number RBYPODJ60

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 09/08/2022

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 renal artery using ruby coils, pod packing coils (pod pcs), and a non-penumbra microcatheter.It should be noted that the patient's anatomy was tortuous.During the procedure, the physician attempted to advance the first ruby coil through its introducer sheath and reported that the coil would not advance at all past its initial position.Therefore, the ruby coil was removed.Next, one non-penumbra coil was implanted and three ruby coils were successfully implanted using the handle.After advancing a pod pc into the target location, the physician made several attempts to detach the coil using a ruby coil detachment handle (handle) without success.Upon removal of the pod pc, the coil detached in the microcatheter.It was reported that the pod pc was completely contained inside the microcatheter; therefore, the microcatheter containing the coil was removed from the patient and the pod pc was flushed out on the back table.The procedure was completed using four other coils and the same microcatheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned pod pc could not confirm the reported complaint.Evaluation revealed that the pet lock was separated on the proximal end of the pusher assembly, the pull wire was retracted out of the ddt, and the embolization coil was detached.This type of damage indicates a successful detachment attempt.Based on the returned condition, the root cause of the reported complaint could not be determined.Penumbra products 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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the reported detachment issue.

• 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 ; 5107483200
• MDR Report Key: 15569908
• MDR Text Key: 305288329
• Report Number: 3005168196-2022-00464
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548017679
• UDI-Public: 814548017679
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBYPODJ60
• Device Lot Number: F111533
• 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: 10/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2021
• 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