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

Model Number	RBYPOD5-A
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the inferior mesenteric artery (ima) using pod coils and a non-penumbra microcatehter.It should be noted that the patient's anatomy was tortuous and calcified.During the procedure, the physician encountered resistance while advancing the pod coil through the distal tip of the microcatheter.The physician decided to remove the coil and, upon withdrawal, noticed that the pod coil was not connected to the pusher wire and was detached inside the microcatheter.It was reported that the pod coil was completely contained inside the microcatheter; therefore, the microcatheter was removed from the patient.Subsequently, the pod coil was removed from the microcatheter.The procedure was completed using another pod coil, a pod packing coil (pod pc), and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned pod5 confirmed a detached embolization coil.Further evaluation revealed the pusher assembly ddt was fractured on the distal end of the pusher assembly.If the pod5 is forcefully retracted against resistance, damage such as this may occur.This damage likely contributed to the embolization coil detaching from the pod5 during the procedure.The root cause of resistance could not be determined.Further evaluation revealed offset coil winds on the embolization coil and pusher assembly kink.This damage was likely incidental to the reported complaint.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.

• Brand Name: POD
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11722048
• Report Number: 3005168196-2021-00851
• Device Sequence Number: 14207797
• Product Code: HCG
• UDI-Device Identifier: 00814548019604
• UDI-Public: 00814548019604
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2021
• 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: RBYPOD5-A
• Device Catalogue Number: RBYPOD5
• Device Lot Number: F97472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/28/2021
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 04/25/2021
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005