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

Model Number	4006C0406
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	12/22/2021
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.This report is associated with mfr report number: 3005168196-2022-00039.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using penumbra coil 400s (pc400s), a px slim delivery microcatheter (px slim), a neuron max 6f 088 long sheath (neuron max), and a neuron delivery catheter 070 (neuron 070).During the procedure, the physician advanced a neuron 070 through the neuron max to the target vessel and then advanced the px slim through the neuron 070 to the target vessel.Next, while advancing a pc400 into the target vessel using the px slim, the physician experienced resistance and subsequently the pc400 unintentionally detached and migrated into the middle cerebral artery (mca).Therefore, the physician used a snare device to remove the detached pc400.Afterwards, while advancing a new pc400 through the px slim, the physician experienced resistance and subsequently the pc400 unintentionally detached with approximately half of the pc400 in the px slim and the other half in the target vessel.Therefore, the px slim containing the detached pc400 was removed.The procedure was completed using other coils, another microcatheter, the same neuron max, and the same neuron 070.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: 13467931
• Report Number: 3005168196-2022-00040
• Device Sequence Number: 14485405
• Product Code: HCG
• UDI-Device Identifier: 00814548011899
• UDI-Public: 00814548011899
• 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
• Report Date (Section B): 02/05/2022
• 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 Model Number: 4006C0406
• Device Catalogue Number: 4006C0406
• Device Lot Number: F101454
• 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: 01/11/2022
• Initial Report FDA Received Date: 02/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2020
• 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: 62 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005