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

Catalog Number	RBYPCLP60
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned packing coil lp confirmed that the embolization coil was detached from the pusher assembly and revealed that the pusher assembly was fractured.If the packing coil lp is advanced against resistance, damage such as a kink and subsequent fracture on the pusher assembly may occur.The fracture on the pusher assembly likely caused the pull wire to retract and the embolization coil to detach from the pusher assembly.It was reported that the patient's anatomy was tortuous.This likely contributed to the resistance.Further evaluation of the device revealed that the pusher assembly was kinked along its length and the pull wire was fractured.This damage was incidental to the complaint and likely 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 or Problem Description
The patient was undergoing a coil embolization procedure to treat an aortic endoleak using packing coil lps and a microcatheter.It should be noted that the patient's anatomy was tortuous.During the procedure, while advancing a packing coil lp through the microcatheter, the physician realized that the packing coil lp had become unintentionally detached within the microcatheter.The physician then used the pusher assembly of the packing coil lp to successfully implant the coil into the target location.The procedure was completed using a ruby coil lp and the same microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: PACKING COIL LP
• 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: 20926604
• Report Number: 3005168196-2024-00415
• Device Sequence Number: 5055920
• Product Code: HCG
• UDI-Device Identifier: 00815948026209
• UDI-Public: 00815948026209
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K230284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/13/2024

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: RBYPCLP60
• Device Lot Number: F00012784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2024
• 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 Age: 81 YR
• Patient Sex: Female