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

Catalog Number	RBYPODJ60
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery using a pod packing coil (packing coil), a non-penumbra coil and a non-penumbra microcatheter.It should be noted that the patient's anatomy was mildly tortuous and mildly calcified.During the procedure, the physician successfully placed a non-penumbra coil into the target vessel using the microcatheter.While advancing the packing coil through the microcatheter, the packing coil became stuck in the distal length of the microcatheter.Upon attempting to retrieve the packing coil, it unintentionally detached within the microcatheter.Therefore, the microcatheter containing the detached packing coil was removed from the patient, and the pod coil was removed from the microcatheter outside of the patient.Subsequent contrast imaging showed that blood flow had ceased.No additional devices were required and the physician then decided to end the procedure.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Evaluation of the returned pod packing coil (packing coil) confirmed that the embolization coil was detached from the pusher assembly.Evaluation revealed that the pet lock was separated on the proximal end of the pusher assembly, and the pull wire was retracted from the distal end of the pusher assembly.This typically occurs during a successful detachment attempt.If the pet lock is inadvertently separated during manipulation of the device, the pull wire may retract out of the pusher assembly distal tip causing the embolization coil to detach from its pusher assembly.Based on the reported complaint, the root cause of the pet lock separating could not be determined.The embolization coil was not returned for evaluation.Further evaluation revealed a kink on the pull tube.This damage was likely incidental to the complaint and may have occurred during packaging of the device for return to penumbra.Penumbra devices 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
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 22128722
• Report Number: 3005168196-2025-00189
• Device Sequence Number: 15292946
• Product Code: HCG
• UDI-Device Identifier: 00814548017679
• UDI-Public: 00814548017679
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: RBYPODJ60
• Device Lot Number: F00012930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown