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

Catalog Number RBYPODJ60

Device Problems Material Deformation (2976); Premature Separation (4045)

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

Event Date 05/16/2022

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the returned pod pc confirmed that the embolization coil was detached from its pusher assembly.Evaluation revealed that the pet lock was separated on the proximal end of the pusher assembly and the pull wire was retracted out of the ddt.If this occurs, by design the embolization coil will detach from the pusher assembly.Further evaluation revealed multiple pusher assembly kinks and fractures.This damage is incidental to the reported complaint and may have occurred during packaging of the device for return.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.

Event Description

The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using 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 successfully implanted one pod pc into the target location.While advancing the next pod pc through the middle of the microcatheter, the physician kinked the proximal end of the pusher wire.Subsequently, the pod pc unintentionally detached in the middle of the microcatheter.Therefore, the microcatheter containing the detached pod pc was removed from the patient and the coil was flushed out on the back table.The procedure was completed using another pod pc of the same size, seven additional pod pcs, and the same microcatheter.There was no report of an adverse effect to the patient.

• 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: 14733873
• MDR Text Key: 301339621
• Report Number: 3005168196-2022-00296
• 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
• Report Date: 01/01/2005,06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• 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: F109853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2022
• 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: 05/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2021
• 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