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

Catalog Number	4002C2860
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2022
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 carotid cavernous fistula (ccf) using a penumbra coil 400 (pc400), a px slim delivery microcatheter (px slim), and a guidewire.It was reported that the patient¿s anatomy was tortuous.During the procedure, the physician experienced resistance while advancing the px slim over the guidewire into the venous pouch.It was reported that after multiple attempts, the guidewire perforated the px slim.Next, the pc400 was advanced into the px slim; however, the pc400 unintentionally detached within the px slim.Therefore, the pc400 was removed.No additional information regarding the completion of the procedure was provided.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the carotid cavernous fistula (ccf) using a penumbra coil 400 (pc400), a px slim delivery microcatheter (px slim), and a guidewire.It was reported that the patient¿s anatomy was tortuous.During the procedure, the physician experienced resistance while advancing the px slim over the guidewire into the venous pouch.It was reported that after excessive manipulation the physician perforated the mid-shaft of the px slim with the guidewire; however, the procedure continued with the same px slim.While advancing the pc400 through the px slim, the physician experienced resistance and subsequently, the pc400 embolization coil was damaged within the px slim.Therefore, the px slim containing the pc400 was removed.The procedure was completed using a new pc400 and the same px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was updated on this follow-up #01 mfr report 3005168196-2023-00047: 1.Section b.Box 5.Describe event or problem: evaluation of the returned pc400 could not confirm that the embolization coil was detached.Evaluation revealed that the embolization coil was intact with the pusher assembly, the embolization coil had offset coil winds, and the pusher assembly had kinks.If the pc400 is advanced against resistance, damage such as offset coil winds on the embolization coil and kinks on the pusher assembly may occur.The resistance was likely due to the damage on the returned px slim.Further evaluation revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock and additional kinks on the pusher assembly.This damage was likely incidental, and the root cause of this damage could not be determined.Due to the returned damage, the pc400 could not be functionally tested during evaluation.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.Note: based on the investigation findings, this is not considered a reportable event.This event did not and, if it were to recur, it would not cause or contribute to serious deterioration or death.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: 16260236
• Report Number: 3005168196-2023-00047
• Device Sequence Number: 11956820
• Product Code: HCG
• UDI-Device Identifier: 00814548011981
• UDI-Public: 814548011981
• 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): 03/16/2023
• 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 Expiration Date: 03/27/2025
• Device Catalogue Number: 4002C2860
• Device Lot Number: F75265
• 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: 01/03/2023
• Supplement Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 01/27/2023
• Supplement Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2017
• 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: 42 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005