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

Model Number	4002C1557
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	01/10/2022
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.This report is associated with mfr report number: 3005168196-2022-00051.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a carotid-cavernous fistula (ccf) using penumbra coil 400s (pc400s), a neuron 6f 070 delivery catheter (neuron 070), a px slim delivery microcatheter (px slim), and a guidewire.During the procedure, the physician successfully implanted two pc400s using the neuron 070 and px slim.Next, the physician experienced resistance while advancing the third pc400 through the px slim.Subsequently, the pc400 unintentionally detached with part of the pc400 in the px slim and the other part in the fistula.Therefore, the physician used the guidewire to push the pc400 into the fistula.Next, the physician experienced resistance while advancing a new pc400 through the px slim.The physician decided to retract the pc400; however, while retracting the pc400, it unintentionally detached inside of the px slim.Therefore, the px slim was removed with the detached pc400 inside.The procedure was ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned pc400 confirmed that the embolization coil was detached from its pusher assembly.Evaluation revealed that the pet lock was separated, the pull wire was retracted out of its distal detachment tip (ddt).This type of damage indicates a successful detachment.If the pet lock is inadvertently separated during retraction of the device and the pull wire is retracted out of the ddt, the embolization will detach from its pusher assembly.Further evaluation revealed pusher assembly kinks and offset coil winds on the embolization coil.This damage was incidental to the reported complaint and the root cause could not be determined.Penumbra coils are visually 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.This report is associated with mfr report number: 1.3005168196-2022-00051.

• 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: 13520970
• Report Number: 3005168196-2022-00052
• Device Sequence Number: 4473342
• Product Code: HCG
• UDI-Device Identifier: 00814548010700
• UDI-Public: 00814548010700
• 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): 04/19/2022
• 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: 4002C1557
• Device Catalogue Number: 4002C1557
• Device Lot Number: F98019
• 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: 01/19/2022
• Supplement Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2020
• 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: 33 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005