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

Model Number	RBYPODJ5-A
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2021
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.This report is associated with mfr report number: 3005168196-2021-02162.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) using pod packing coils (pod pc), ruby coils, a ruby coil detachment handle (handle), and a lantern delivery microcatheter (lantern).During the procedure, the physician placed two ruby coils and four pod pcs in the target vessel using the handle.The physician then attempted to advance another pod pc; however, the pod pc was stuck and would not advance out its introducer sheath.Therefore, the pod pc was removed.The physician then placed a new pod pc in vessel using the handle.Subsequently, the physician advanced the last pod pc into the vessel and attempted to detach it using a handle; however, the pod pc failed to detach.Therefore, the pod pc was removed.The physician was satisfied with the packing density and decided to end the procedure.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned pod pc confirmed, the reported complaint.Evaluation revealed, a kink on the proximal end of the pusher assembly.This damage is likely, the probable cause of the reported complaint.During functional testing, the pod pc embolization coil was advanced out of the introducer sheath without an issue.However, the entire pod pc could not be advanced through the introducer sheath, due to the pusher assembly kink.If the pusher assembly is mishandled at extreme angles during use, damage such as a kink may occur.Penumbra coils are 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: 1.3005168196-2021-02162.H3 other text: placeholder.

• Brand Name: POD PACKING COIL
• 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: 12558703
• Report Number: 3005168196-2021-02161
• Device Sequence Number: 12702438
• Product Code: HCG
• UDI-Device Identifier: 00814548017631
• UDI-Public: 00814548017631
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K170852
• 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): 11/11/2021
• 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 Model Number: RBYPODJ5-A
• Device Catalogue Number: RBYPODJ5
• Device Lot Number: F92726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• 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: 09/07/2021
• Supplement Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2019
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/01/2005