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

Catalog Number	RBYPODJ30
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in a veno-venous (vv) shunt of the pulmonary veins using a lantern delivery microcatheter (lantern), pod packing coils (packing coil), and an angiographic catheter.It should be noted that the patient¿s anatomy was mildly tortuous and mildly calcified.During the procedure, the physician successfully implanted four ruby coils and six packing coils into the target vessel using the lantern.While advancing the packing coil as the eleventh coil, the physician noticed the coil was not following and had unintentionally detached when it was partially out of the tip of the lantern.Therefore, the detached packing coil was removed with the lantern, and the packing coil was flushed out of the lantern.The procedure was continued, and eight more packing coils were successfully implanted using the same microcatheter.However, another packing coil was also noticed to not be following and had unintentionally detached when its entire length was outside of the microcatheter.A snare was used to remove the detached packing coil from the target vessel.The physician confirmed the shunt flow had dropped and decided to end the procedure.There was no report of an adverse effect to the patient.
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: 3005168196-2024-00367.H3 other text: placeholder.
Additional Manufacturer Narrative
Evaluation of the returned packing coil confirmed that the embolization coil was detached from the pusher assembly.Evaluation revealed that the pet lock was intact and the pull wire was in its initial position within the pusher assembly distal tip.If the packing coil is retracted against resistance, the pusher assembly may elongate beyond the reach of the pull wire causing the embolization coil to detach.The reported mildly tortuous and calcified anatomy may have contributed to the resistance experienced during procedure.Further evaluation revealed that the pusher assembly was kinked at the proximal end.This damage is incidental to the reported complaint and likely occurred during packaging for return.Evaluation of the returned embolization coil confirmed that the embolization coil was detached from its pusher assembly.The pusher assembly was not returned for evaluation.Based on the return condition, the root cause of the reported complaint could not be determined.Further evaluation revealed offset coil winds on the embolization coil.This damage is likely incidental to the complaint and may have occurred due to manipulation against resistance during use.The reported mildly tortuous and calcified patient¿s anatomy may have contributed to resistance during the procedure.Further evaluation also revealed unknown residue on the embolization coil.This damage was incidental to the reported complaint and may have occurred during handling of the device.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.This report is associated with mfr report number: 3005168196-2024-00367.

• 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: 20606672
• Report Number: 3005168196-2024-00366
• Device Sequence Number: 12745125
• Product Code: HCG
• UDI-Device Identifier: 00814548017655
• UDI-Public: 00814548017655
• 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,Followup
• Report Date (Section B): 11/14/2024
• 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: RBYPODJ30
• Device Lot Number: F00010276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2024
• 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: 10/10/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2024
• 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