MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Catalog Number	4004C0615
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	04/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned pc400 confirmed that the embolization coil was detached from the pusher assembly and revealed that the pusher assembly was kinked and fractured.If the pc400 is advanced against resistance during use, damage such as kink and fracture on the pusher assembly may occur.If the pusher assembly is fractured, the pull wire may retract from the distal tip of the pusher assembly, causing the embolization coil to detach.Further evaluation revealed offset coil winds along the length of the embolization coil.This damage may have occurred during advancement against resistance and during removal of the coil from the 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right vertebral artery using a penumbra coil 400 (pc400), a px slim delivery microcatheter (px slim), and a non-penumbra long sheath.During the procedure, the physician experienced resistance while attempting to advance the pc400 through the px slim.The physician then attempted to remove the pc400 and experienced resistance.It was reported that the pc400 became stuck and unintentionally detached.The physician then used a snare device to remove the pc400 from the patient.The physician decided to use smaller diameter coils to continue the procedure and therefore, discontinued use of the px slim.The procedure was completed using non-penumbra coils and a non-penumbra microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: 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: 20313324
• Report Number: 3005168196-2024-00330
• Device Sequence Number: 18143997
• Product Code: HCG
• UDI-Device Identifier: 00814548010885
• UDI-Public: 00814548010885
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K103305
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/26/2024
• Report Date (Section F): 01/01/2005

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: 4004C0615
• Device Lot Number: F106756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2021
• 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: 55 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005