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

Catalog Number	RBYPODJ15
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned pod packing coil pusher assembly confirmed that the embolization coil was detached, and the pusher assembly was kinked.If the packing coil is advanced against resistance, damage such as a kink on the pusher assembly may occur.Further evaluation revealed that the pull wire was in its initial position inside the pusher assembly distal tip.If the device is retracted against resistance, the pusher assembly may elongate beyond the reach of the pull wire and result in the embolization coil detachment.The detached embolization coil was not returned for evaluation.Based on the reported complaint, the root cause of resistance could not be determined.Further evaluation of the device revealed additional kinks throughout the length of the pusher assembly.This damage was incidental to the reported complaint and occurred during packaging for return to penumbra.Penumbra devices are visually 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.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the inferior mesenteric artery (ima) using a lantern delivery microcatheter (lantern), a pod packing coil (packing coil), and a ruby coil.It should be noted that the patient¿s anatomy was mildly tortuous.During the procedure, the physician successfully implanted one ruby coil into the target vessel using the lantern.While advancing the packing coil through the lantern, the physician experienced resistance and the packing coil stopped advancing.The physician removed the packing coil.After inspecting the packing coil, the physician attempted to advance the packing coil through the lantern again; however, resistance was still encountered.While advancing the packing coil against resistance, the physician kinked the pusher assembly of the packing coil.While retracting the packing coil, it unintentionally detached within the lantern.Therefore, the lantern containing the packing coil was removed.The physician then determined that the target vessel was sufficiently embolized and the procedure ended.There was no report of an adverse effect to the patient.

• 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: 20242028
• Report Number: 3005168196-2024-00323
• Device Sequence Number: 15494742
• Product Code: HCG
• UDI-Device Identifier: 00814548017648
• UDI-Public: 00814548017648
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 09/17/2024
• 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: RBYPODJ15
• Device Lot Number: F00005796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2024
• 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: 08/22/2024
• Initial Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2023
• 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: 84 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005