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

Catalog Number RBYPODJ15

Device Problems Failure to Fold (1255); Premature Separation (4045)

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

Event Date 11/22/2022

Event Type  malfunction  

Event Description

The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using pod packing coils (pod pcs), a lantern delivery microcatheter (lantern), and a non-penumbra catheter.During the procedure, the physician successfully implanted one non-penumbra coil and five pod pcs.After advancing the next pod pc into the target location, the physician made approximately six attempts to get the pod pc to take the desired shape and was unsuccessful.Subsequently, the physician noticed that the pod pc was unintentionally detached inside the lantern during an attempt to move the coil by hand while visualizing it on the angiogram.Therefore, the lantern containing the detached pod pc was removed and the pod pc was flushed out on the back table.The procedure was completed using the same lantern to implant another pod pc of the same size.There was no report of an adverse effect to the patient.

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.

Manufacturer Narrative

Evaluation of the returned pod pc pusher assembly confirmed that the embolization coil was detached.Evaluation revealed that the pet lock was separated, and the pull wire was retracted from the pusher assembly.Based on the reported event, this likely occurred during the attempts to place the coil or manipulation of the coil during the procedure.If the pet lock is manipulated during the procedure, the pet lock may separate, and the pull wire may retract from the pusher assembly.This likely contributed to the reported coil detachment during the procedure.The detached embolization coil was not returned for evaluation.Further evaluation of the device revealed a fracture and a kink on the pusher assembly.Based on the reported event, this damage was likely incidental to the complaint and likely occurred during packaging for the device return.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.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 ; 5107483200
• MDR Report Key: 16038339
• MDR Text Key: 308451268
• Report Number: 3005168196-2022-00591
• Device Sequence Number: 1
• Product Code: HCG
• 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: 01/01/2005,01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBYPODJ15
• Device Lot Number: F110708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2022
• 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: 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2021
• 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