MAUDE Adverse Event Report: PENUMBRA, INC. POD8; HCG, KRD

Catalog Number	RBYPOD8
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2019
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.This report is associated with mfr report number: 3005168196-2019-01889.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the hypogastric artery using pod8s and ruby coils.It was noticed that the patient had an acute angle into the hypogastric artery.During the procedure, the physician placed a non-penumbra guide catheter in the target vessel and then advanced a lantern delivery microcatheter (lantern) over a non-penumbra guidewire into the aneurysm.Next, the physician advanced a pod8 through the lantern; however, after advancing approximately half of the pod8 out of the lantern, the physician experienced resistance and the pod8 became stuck and would not advance any further.The physician then attempted to remove the pod8; however, while retracting the pod8, it unintentionally detached.Therefore, the physician removed the lantern containing the detached pod8 and then removed the pod8.While advancing a new pod8 through the same lantern, the physician experienced resistance and subsequently, after advancing approximately 75 percent of the pod8 out of the lantern, the pod8 unintentionally detached.Therefore, the physician removed the lantern containing the detached pod8 and then removed the pod8.It was also reported that the physician inspected the lantern upon removal; however, no issues or kinks were found.The guide catheter was then repositioned, and the physician successfully placed a pod6 and four ruby coils in the target vessel using the same lantern.While attempting to place another ruby coil, it was inadvertently dropped on the floor upon removal from the packaging.Therefore, the ruby coil was not used in the procedure.The procedure was completed using a new ruby coil and the same lantern.There was no report of an adverse effect to the patient.

• Brand Name: POD8
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9169849
• Report Number: 3005168196-2019-01888
• Device Sequence Number: 2591877
• Product Code: HCG
• UDI-Device Identifier: 00814548013831
• UDI-Public: 00814548013831
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K141134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2019
• 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 Expiration Date: 06/25/2024
• Device Catalogue Number: RBYPOD8
• Device Lot Number: F70304
• Was Device Available for Evaluation?: No
• 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: 09/10/2019
• Initial Report FDA Received Date: 10/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Date Report Sent to FDA: 01/01/2005