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

Catalog Number RBYPODJ45

Device Problem Premature Separation (4045)

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

Event Date 02/08/2024

Event Type  malfunction  

Event Description

The patient was undergoing a coil embolization procedure in the subclavian artery using a lantern delivery microcatheter (lantern) and packing coils (pcs).During the procedure, the physician successfully implanted non-penumbra coils into the target vessel using the lantern.While attempting to advance a pc into the target vessel, the physician determined that the pc did not fit in the vessel.After several strokes of retracting the pc, the coil unintentionally detached within the lantern.Therefore, the lantern containing the pc was removed.The procedure was completed using a new lantern and another pc.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.H3 other text : placeholder.

Event Description

The patient was undergoing a coil embolization procedure in the subclavian artery using a lantern delivery microcatheter (lantern) and packing coils (pc).It should be noted that the patient¿s anatomy was mildly tortuous.During the procedure, the physician successfully implanted non-penumbra coils into the target vessel using the lantern.While attempting to advance a pc into the target vessel, the physician determined that the pc did not fit in the vessel.After several strokes of retracting the pc, the physician noticed via contrast imaging that the coil unintentionally detached within the lantern.Therefore, the lantern containing the pc was removed.The procedure was completed using a new lantern and another pc.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following section is being updated based on additional information provided by the distributor on 04/01/2024: 1.Section b.Box 5.Describe event or problem.Evaluation of the returned pod pc confirmed that the embolization coil was detached from the pusher assembly.Evaluation revealed that the pusher assembly was fractured on the proximal end, and the pull wire was retracted out of the pusher assembly distal tip.This likely contributed to the embolization coil unintentionally detaching during the procedure.If the proximal end of the device is manipulated at angles during advancement against resistance, damage such as a kink and subsequent fracture may occur.The reported tortuous patient¿s anatomy may have contributed to resistance during the procedure.Further evaluation revealed offset coil winds along the embolization coil.This damage may have occurred due to manipulation against resistance or during packaging for return to penumbra.Penumbra devices 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: 18983957
• MDR Text Key: 338769148
• Report Number: 3005168196-2024-00107
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548017662
• UDI-Public: 814548017662
• 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: 01/01/2005,04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBYPODJ45
• Device Lot Number: F00008257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2024
• 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: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2023
• 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