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

Model Number RBYPODJ45-A

Device Problems Unraveled Material (1664); Premature Separation (4045)

Patient Problem Vasoconstriction (2126)

Event Date 02/02/2021

Event Type  Injury  

Manufacturer Narrative

Evaluation of the returned pod pc confirmed that the embolization coil was detached from its pusher assembly and was unraveled.Further evaluation of the returned pod pc revealed that the pe-fiber was fractured.This type of damage typically occurs if the pod pc is forcefully retracted or manipulated against resistance.The complaint stated that several attempts were made to re-position the pod pc.This damage likely resulted in the embolization coil detaching from its pusher assembly.Some of the damage may have occurred while snaring the embolization coil during removal.The damage to the lantern mentioned in the complaint could not be confirmed.The lantern was not returned for evaluation.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.

Event Description

The patient was undergoing a coil embolization procedure in the collateral vessels off the subclavian artery using pod packing coils (pod pcs) and a lantern delivery microcatheter (lantern).During the procedure, the physician made several attempts to re-position the pod pc and during one attempt approximately four fifths of the coil was inside a collateral vessel off of the right subclavian artery when the lantern kicked out and the pod pc detached.The physician used a snare to pull the detached coil into the lantern.Approximately half-way through removal of the pod pc, the collateral vessel spasmed.The physician pulled the snare back with more force and upon removal of the lantern containing the pod pc from the patient, the physician noticed that the coil had unraveled.On the back table, before re-advancing the lantern, the physician noticed the lantern tip was compressed.Therefore, the lantern was no longer used in the procedure.Due to the patient's age, it was reported that no medical treatment was administered to treat the vasospasm.Therefore, the physician gave the patient's vessel time to relax before re-accessing it and implanting two ruby coils using a new lantern.The procedure was completed successfully and the patient is stable.

• 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: 11416351
• MDR Text Key: 234973255
• Report Number: 3005168196-2021-00404
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548017662
• UDI-Public: 00814548017662
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K170852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RBYPODJ45-A
• Device Catalogue Number: RBYPODJ45
• Device Lot Number: F98113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• 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: 02/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 9 YR
• Patient Weight: 32