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

Catalog Number RBYPODJ30-A

Device Problems Failure to Advance (2524); Premature Separation (4045)

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

Event Date 10/06/2022

Event Type  malfunction  

Event Description

The patient was undergoing a coil embolization procedure to treat an esophageal varix using a pod packing coil (pod pc) and a lantern delivery microcatheter (lantern).During the procedure, a combination of three packing coil and ruby coil was placed in the target vessel using the lantern.Next, while attempting to advance the pod pc, the pod pc would not advance through the lantern.Therefore, the physician decided to remove the pod pc.While attempting to remove the pod pc, the pod pc unintentionally detached inside the lantern.The physician aspirated the detached pod pc using a syringe and removed the pod pc and the lantern.The procedure ended at this point and no additional coils were placed.There was no report of an adverse effect to the patient.

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coil was detached from its pusher assembly.Evaluation revealed that the pet lock was separated, and the pull wire was retracted.This typically occurs during a successful detachment attempt.If the pull wire is retracted, the embolization coil will likely detach from its pusher assembly.Retraction of the pull wire is likely what caused the reported detachment during the procedure.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.

• 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: 15710044
• MDR Text Key: 304629732
• Report Number: 3005168196-2022-00511
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548017655
• UDI-Public: 814548017655
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBYPODJ30-A
• Device Lot Number: F00000916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2022
• 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
• Initial Date Manufacturer Received: 10/06/2022
• Initial Date FDA Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2022
• 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: 37 YR
• Patient Sex: Female