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

Catalog Number RBYPODJ15

Device Problems Break (1069); Physical Resistance/Sticking (4012); Premature Separation (4045)

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

Event Date 10/04/2023

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the returned pod pc confirmed that the pusher assembly was fractured, and the embolization coil was detached.If the device is advanced against resistance, damage such as a kink in the pusher assembly may occur.Subsequently, if a kinked device is further manipulated, the kink may worsen to a fracture.The detached embolization coil was likely due to the fractured pusher assembly being separated, and the pull wire retracting out of the pusher assembly distal tip.Based on the reported complaint, the root cause of resistance could not be determined.Further evaluation revealed offset coil winds on the embolization coil.This damage may be incidental to the complaint and may have occurred during packaging for return to penumbra.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 right axillary artery using pod packing coils (pod pc) and a non-penumbra microcatheter.During the procedure, the physician successfully implanted one non-penumbra coil and one pod pc into the target vessel using the microcatheter.While advancing another pod pc into the microcatheter, the physician experienced resistance, but continued to advance the pod pc.After advancing the pod pc against resistance through the mid-shaft of the microcatheter, the physician decided to remove the pod pc.Upon removal the physician found that the pusher assembly of the pod pc had fractured and that the pod pc unintentionally detached inside the microcatheter.Therefore, the microcatheter containing the pod pc was removed.On the back table, the pod pc was flushed out of the microcatheter.The procedure was completed using a new pod pc.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: 18136292
• MDR Text Key: 328138303
• Report Number: 3005168196-2023-00510
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548017648
• UDI-Public: 814548017648
• 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: 01/01/2005,11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBYPODJ15
• Device Lot Number: F00000112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2023
• 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: 10/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2022
• 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: 7 YR
• Patient Sex: Female