MAUDE Adverse Event Report: PENUMBRA, INC. PAC400 COIL; HCG, KRD

Catalog Number	400PAC40
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2023
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.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the vertebral artery using a pac400 coil and a px slim delivery microcatheter (px slim).It was reported that the patient¿s anatomy was tortuous.During the procedure, the physician successfully placed a pod coil in the target location using the ruby coil detachment handle (handle).The pac400 was then advanced through the px slim up the right vertebral and down the left vertebral artery to the target location and the physician noticed that the pac400 had unintentionally detached.It was reported that the pac400 was not secure in the target vessel.A snare device was used to retrieve the pac400.The procedure was completed at this point and the physician decided no additional coils were needed.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections are being updated based on additional information provided by a penumbra sales representative on 13dec23: 1.Section d.Box 4.Lot# 2.Section d.Box 4.Expiration date 3.Section d.Box 4.Udi device investigation evaluation of the returned (b)(6) confirmed that the embolization coil was detached.Evaluation revealed that the pusher assembly was not returned for evaluation.Therefore, the root cause of the reported unintentional detachment of the coil could not be determined.Further evaluation revealed offset coil winds on the embolization coil.This damage was incidental to the reported complaint and may have occurred during snaring attempts to retrieve the coil.Penumbra devices 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.H3 other text : placeholder.

• Brand Name: PAC400 COIL
• 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: 18298354
• Report Number: 3005168196-2023-00545
• Device Sequence Number: 15212460
• Product Code: HCG
• UDI-Device Identifier: 00815948021334
• UDI-Public: 815948021334
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2024
• 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: 400PAC40
• Device Lot Number: F00007113
• Was Device Available for Evaluation?: Yes
• 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: 11/14/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 12/09/2023
• Supplement Report FDA Received Date: 01/20/2024
• 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: 16 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005