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

Catalog Number	4006C0203
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	10/22/2022
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 a1 segment of the anterior cerebral artery using a neuron max 6f 088 long sheath (neuron max), a px slim delivery microcatheter (px slim), a penumbra coil 400 (pc400), and a non-penumbra catheter.During the procedure, the physician advanced the px slim into the target vessel using the neuron max and catheter.Next, while advancing the pc400 through the px slim, the physician experienced resistance and decided to retract the pc400.Upon retraction, the pc400 unintentionally detached and was stuck within the px slim.Therefore, the px slim containing the detached pc400 was removed from the patient.The procedure was completed using three non-penumbra coils, the same neuron max, the same catheter, and a non-penumbra microcatheter.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 the distributor on 11/22/2022:  1.Section a.Box 1.Patient identifier.  evaluation of the returned pc400 confirmed that the embolization coil was detached from the pusher assembly, and the pusher assembly was not returned for evaluation.Further evaluation revealed that the sr component was fractured, and the embolization coil had offset coil winds.This type of damage may occur if the device is manipulated against resistance during use.The fractured sr component likely contributed to the coil detaching.The root cause of resistance during the procedure could not be determined.Penumbra coils and catheters 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: 15845516
• Report Number: 3005168196-2022-00556
• Device Sequence Number: 5981987
• Product Code: HCG
• UDI-Device Identifier: 00814548011776
• UDI-Public: 814548011776
• 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): 12/08/2022
• 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: 4006C0203
• Device Lot Number: F108956
• 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: 10/30/2022
• Supplement Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2021
• 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: 57 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005