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

Catalog Number	4004C0820
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using a px slim delivery microcatheter (px slim) and a penumbra coil 400 (pc400).During the procedure, after advancing part of the pc400 into the target vessel, it unintentionally detached.Therefore, the physician used a stent retriever to remove the detached pc400.The px slim was then removed and was no longer used in the procedure.The procedure was completed using a non-penumbra microcatheter and non-penumbra coils.There was no report of an adverse effect to the patient.
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.H3 other text : placeholder.
Additional Manufacturer Narrative
Please note that the device in complaint was not expected to be returned; however, on 28-nov-23 the device was received.Based on this information, corrections were made to: 1.Section d.Box 10: device available for evaluation? (do not send to fda) and returned to manufacturer on (mm/dd/yyyy) 2.Section h.Box 3: device returned to manufacturer? 3.Section h.Box 3: device evaluated by manufacturer? 4.Section h.Box 6: method code 1 and method code 2 5.Section h.Box 6: results code 1, results code 2, and results code 3 6.Section h.Box 6: conclusions code 1 additional information was added to: 1.Section d.Box 10: returned to manufacturer on (mm/dd/yyyy) evaluation of the returned pc400 confirmed that the embolization coil was detached from the pusher assembly and revealed that the pusher assembly was kinked and fractured on its proximal end.The root cause of the proximal end damage could not be determined.If the pusher assembly is fractured, the pull wire may retract causing the embolization coil to detach.Further evaluation revealed offset coil winds on the embolization coil.This damage may have occurred during removal of the coil from the procedure.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: 17892604
• Report Number: 3005168196-2023-00453
• Device Sequence Number: 7695522
• Product Code: HCG
• UDI-Device Identifier: 00814548010922
• UDI-Public: 814548010922
• 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): 01/05/2024
• 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: 4004C0820
• Device Lot Number: F99883
• 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: 09/10/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 10/07/2023
• Supplement Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2020
• 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: 45 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005