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

Catalog Number	4004C0513
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	08/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the supraclinoid internal carotid artery (ica) using penumbra coil 400s, a px slim delivery microcatheter (px slim), a neuron 6f 070 delivery catheter (neuron 070), and a neuron max 6f 088 long sheath (neuron max).During the procedure, the physician successfully implanted two pc400s into the target location using the px slim.While advancing the next pc400 through the px slim, the physician experienced resistance and noticed that the pc400 had unintentionally detached when the coil was partially within the px slim and partially within the vessel.Therefore, the physician used a stent retriever to assist with the removal of the pc400.The procedure was completed using a new pc400, the same px slim, the same neuron 070, and the same neuron max.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 pc400 confirmed that the embolization coil was detached and revealed that the sr component was fractured.If the pc400 is retracted against resistance, the sr component may fracture resulting in the embolization coil becoming detached.Further evaluation revealed that the pet lock was separated, and the pusher assembly was kinked.This damage was incidental to the reported complaint.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.

• 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: 17804207
• Report Number: 3005168196-2023-00436
• Device Sequence Number: 15298651
• Product Code: HCG
• UDI-Device Identifier: 00814548010861
• UDI-Public: 814548010861
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K120330
• 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,Followup
• Report Date (Section B): 12/14/2023
• 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: 4004C0513
• Device Lot Number: F102100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/29/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2020
• 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: 38 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005