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

Model Number	4004J25
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 left transverse sinus using penumbra coil 400s (pc400), a neuron 6f 070 delivery catheter (neuron 070), a px slim delivery microcatheter (px slim), and a guidewire.During the procedure, the physician placed the neuron 070 into the patient, then advanced the px slim through the neuron 070.While advancing the pc400 through the px slim, the physician inadvertently advanced the pc400 in the wrong channel of the vessel; therefore the physician decided to pull back and reposition the pc400.However, while retracting the pc400, it unintentionally detached within the px slim.Therefore, the px slim containing the detached pc400 was removed.The procedure was completed using a pac400 coil, the same neuron 070 and px slim.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: 13755305
• Report Number: 3005168196-2022-00119
• Device Sequence Number: 20076245
• Product Code: HCG
• UDI-Device Identifier: 00814548011721
• UDI-Public: 00814548011721
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2022
• 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 Expiration Date: 02/20/2026
• Device Model Number: 4004J25
• Device Catalogue Number: 4004J25
• Device Lot Number: C26037
• Was Device Available for Evaluation?: No
• 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: 02/14/2022
• Initial Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2018
• 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: 62 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005