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

Catalog Number	4002C0925
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a portal arteriovenous malformation (avm) using penumbra coil 400s (pc400s) and a px slim delivery microcatheter (px slim).During the procedure, the physician successfully implanted a pc400 into the target location.The physician then advanced another pc400 into the target location; however, while attempting to reposition the pc400, the coil unintentionally detached.The physician then removed the detached pc400 using a stent retriever.The procedure was completed using another pc400, a pac400, and the same px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned pc400 confirmed that the embolization coil was detached.Evaluation revealed that proximal constraint sphere was intact on the proximal end of the embolization coil and the pusher assembly was not returned for evaluation.Based on the returned condition, the root cause of the reported unintentional detachment during the procedure 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 removal from the patient¿s body.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.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: 19386624
• Report Number: 3005168196-2024-00201
• Device Sequence Number: 17148793
• Product Code: HCG
• UDI-Device Identifier: 00814548010571
• UDI-Public: 814548010571
• 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): 06/06/2024
• 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: 4002C0925
• Device Lot Number: F97168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2024
• 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: 04/30/2024
• Supplement Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2020
• 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