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

Catalog Number	4002C1857
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	01/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a right carotid cavernous fistula (ccf) using penumbra coil 400s (pc400s) and a px slim delivery microcatheter (px slim).During the procedure, the physician advanced a pc400 into the carotid sinus and noticed that the pc400 was oversized.Therefore, the physician decided to remove the coil.While retracting the pc400, the pc400 unintentionally detached, with part of the coil within the microcatheter and the other part in the mid-aorta.The physician then used a snare to retrieve the detached pc400.The procedure was completed using five additional pc400s and the same px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.H3 other text : placeholder.
Additional Manufacturer Narrative
Please note that the following sections are being updated based on additional information provided by a penumbra distributor on 05/03/2024: 1.Section b.Box 5.Describe event or problem.2.Section h.Box 6.Device code 1 and device code 2 h3 other text : placeholder.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a right carotid cavernous fistula (ccf) using penumbra coil 400s (pc400s) and a px slim delivery microcatheter (px slim).During the procedure, the physician advanced a pc400 into the carotid sinus and noticed that the pc400 was oversized.Therefore, the physician decided to remove the coil.While retracting the pc400, resistance was experienced and the pc400 unintentionally detached.It was reported that part of the coil within the microcatheter and the other part in the mid-aorta.The physician then used a snare to retrieve the detached pc400.The procedure was completed using five additional pc400s 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 incorrectly reported on the initial mfr report and is being corrected on this follow-up #2 mfr report: 3005168196-2024-00169 1.Section d.Box 4.Unique identifier evaluation of the returned pc400 confirmed that the embolization coil was detached from the pusher assembly.Evaluation revealed that the pet lock was intact on the proximal end of the pusher assembly, the pull wire was in its initial position inside the pusher assembly distal tip, and the embolization coil was detached.If the pc400 is retracted against resistance, the pusher assembly may elongate beyond the reach of the pull wire and allow the embolization coil to detach.Based on the reported complaint, the root cause of resistance during the procedure could not be determined.Further evaluation revealed offset coil winds on the embolization coil.This damage was likely incidental to the complaint and may have occurred during retrieval of the detached coil or during packaging for return to penumbra.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.

• 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: 19235032
• Report Number: 3005168196-2024-00169
• Device Sequence Number: 6980480
• Product Code: HCG
• UDI-Device Identifier: 00814548019345
• UDI-Public: 00814548019345
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K173614
• 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,Followup
• Report Date (Section B): 06/25/2024
• 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: 4002C1857
• Device Lot Number: F00007431
• 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: 04/10/2024
• Supplement Date Received by Manufacturer: 05/03/2024; 06/13/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 05/30/2024; 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 24 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005