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

Catalog Number	400POD4
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2022
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 left vertebral artery using a pod400 coil, non-penumbra coils, a non-penumbra microcatheter, and a non-penumbra catheter.During the procedure, the physician placed two non-penumbra coils in the target location using the microcatheter.Next, while advancing a pod400 into the target location using the microcatheter, it was reported that the physician pulled back after the pod400 was partially advanced into the artery.Consequently, the pod400 had unintentionally detached inside the microcatheter.Therefore, the physician advanced the catheter over the microcatheter and detached pod400 and removed the catheter, microcatheter and detached pod400 together as a unit.The physician performed an angiogram and was satisfied with the packing density and ended the procedure at this point.There was no report of an adverse effect to the patient.

• Brand Name: POD
• 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: 14886752
• Report Number: 3005168196-2022-00317
• Device Sequence Number: 5162860
• Product Code: HCG
• UDI-Device Identifier: 00815948020337
• UDI-Public: 815948020337
• 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): 07/01/2022
• 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: 400POD4
• Device Lot Number: F90825
• 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: 06/09/2022
• Initial Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2019
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Date Report Sent to FDA: 01/01/2005