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

Model Number	4004J25
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	02/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the ophthalmic artery using penumbra coils 400 (pc400) and a lantern delivery microcatheter (lantern).During the procedure, the physician experienced resistance while advancing a pc400 through a lantern.Subsequently, the pc400 unintentionally detached inside the lantern.Therefore, the lantern containing the detached pc400 was removed.The procedure ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra sales representative on 04/07/2021: 1.Section b.Box 5.5.Describe event or problem.Evaluation of the returned pc400 confirmed the embolization coil was detached from the pusher assembly.Further evaluation revealed that the proximal constraint sphere was detached from the embolization coil due to a fractured sr wire, and was within the pusher assembly ddt.If the pc400 is forcefully retracted against resistance, damage such as this may occur.Further evaluation revealed offset coil winds throughout the length of the embolization coil and pusher assembly bends.This damage was likely incidental to the reported complaint.Evaluation of the returned lantern revealed a functional device.During functional testing, a demonstration pc400 was advanced through the lantern without an issue.The root cause of resistance could not be determined.Penumbra coils 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the ophthalmic artery using penumbra coils 400 (pc400) and a lantern delivery microcatheter (lantern).During the procedure, the physician successfully placed approximately eight penumbra coils into the target vessel using the lantern.Afterwards, the physician experienced resistance while advancing a pc400 through the lantern.Subsequently, the pc400 unintentionally detached inside the lantern.Therefore, the lantern containing the detached pc400 was removed.The procedure ended at this point.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
• MDR Report Key: 11602739
• Report Number: 3005168196-2021-00654
• Device Sequence Number: 11667969
• Product Code: HCG
• UDI-Device Identifier: 00814548011721
• UDI-Public: 00814548011721
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2021
• 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 Expiration Date: 04/08/2025
• Device Model Number: 4004J25
• Device Catalogue Number: 4004J25
• Device Lot Number: F75498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 05/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Date Report Sent to FDA: 01/01/2005