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

Catalog Number	4004C0412
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	12/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in origin of the posterior communicating artery (pcom) using penumbra coil 400s (pc400s), a px slim delivery microcatheter (px slim), and a guidewire.It should be noted that the patient''s anatomy was tortuous.During the procedure, the physician experienced resistance while advancing the pc400 and reported that the coil unintentionally detached in the middle of the px slim.Therefore, the physician removed the px slim containing the pc400 and flushed the coil out of the px slim using a three ml syringe.The physician then re-introduced the same px slim into the target location and attempted to implant another pc400.While retracting the pc400 for re-positioning, the pcom dissected causing thrombosis of the aneurysm and part of the pcom.Therefore, the pc400 was removed intact.The physician then administered an antiplatelet drug.The procedure was ended at this point.
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 1.3005168196-2024-00025.
Additional Manufacturer Narrative
Evaluation of the returned pc400 confirmed a detached embolization coil.Further evaluation revealed that the sr component was fractured, and the embolization coil had offset coil winds.This damage typically occurs due to retraction against resistance.If the sr component fractures, embolization coil will likely detach.Based on the reported event, the root cause of resistance could not be determined.The pusher assembly was not returned for evaluation.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.This report is associated with mfr report number: 3005168196-2024-00025.

• 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: 18509138
• Report Number: 3005168196-2024-00024
• Device Sequence Number: 15404245
• Product Code: HCG
• UDI-Device Identifier: 00814548010847
• UDI-Public: 814548010847
• 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): 02/10/2024
• 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: 4004C0412
• Device Lot Number: F108423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2024
• 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: 12/17/2023
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 02/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2021
• 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: 37 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005