MAUDE Adverse Event Report: PENUMBRA, INC. POD400; HCG, KRD

Catalog Number	400POD6
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2023
Type of Reportable Event	Malfunction
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.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using a pod400 coil and a px slim delivery microcatheter (px slim).It was noted that the patient¿s anatomy was mildly tortuous.During the procedure, the physician began to manipulate the proximal section of the px slim and it folded on itself.Subsequently, the pod400 coil unintentionally detached with 5cm of coil outside of the px slim within the vessel.Therefore, the physician removed the px slim and pod400 coil.The procedure was completed with a new px slim and pc400 coils.There was no report of an adverse effect to the patient.

• Brand Name: POD400
• 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: 18025881
• Report Number: 3005168196-2023-00481
• Device Sequence Number: 7615833
• Product Code: HCG
• UDI-Device Identifier: 00815948020351
• UDI-Public: 815948020351
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• 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
• Report Date (Section B): 10/27/2023
• 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: 400POD6
• Device Lot Number: F88008
• Was Device Available for Evaluation?: No
• 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: 10/02/2023
• Initial Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2019
• 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: 40 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005