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 06/15/2022

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 splenic artery using pod packing coils (pod pcs), a lantern delivery microcatheter (lantern), and an angiographic catheter.During the procedure, the physician successfully implanted six coils and two pod pcs.While advancing the next pod pc through the lantern, the coil unintentionally detached.Upon removal, the physician kinked the pod pc pusher wire.Therefore, the lantern containing the detached pod pc was removed from the patient and the pod pc was flushed out on the back table.The procedure was completed using another pod pc of the same size, the same lantern, and the same angiographic catheter.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 the pusher assembly.Further evaluation revealed that the pull wire was in its initial position within the pusher assembly ddt, and the embolization coils proximal constraint sphere was inside the ddt.If the pod pc is retracted against resistance, the embolization coils stretch resistant (sr) component may fracture, and the embolization coil will detach.This damage likely contributed to the unintentional detachment.Further evaluation revealed that the pet lock was separated, the pusher assembly was fractured, and the pull tube was bent on the proximal end of the pusher assembly.This damage was incidental to the reported complaint and likely occurred during the post 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: 15041299
• MDR Text Key: 304679705
• Report Number: 3005168196-2022-00338
• 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: 01/01/2005,08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• 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: F108655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2022
• 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: 07/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2021
• 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
• Patient Age: 73 YR
• Patient Sex: Male