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

Catalog Number	RBYPODJ45
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using a packing coil (pc) and a lantern delivery microcatheter (lantern).During the procedure, the physician advanced the pc into the target location using the lantern; however, the pc was determined to be too long.Therefore, the physician decided to remove the pc.While retracting the pc, the coil unintentionally detached inside the lantern and partially in the hepatic artery.Therefore, the physician used a stent to secure the detached pc in the hepatic artery to prevent the pc from moving.It was reported that the physician did not initially attempt to remove the detached pc using a snare device due to the potential difficulty it could cause as the pc was partially within previously implanted coils.The procedure ended at this point.
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.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: 3005168196-2024-00148.1.Section b.Box 5.Describe event or problem.Emboli is included as a possible complication in the instructions for use (ifu) for the pod system.Evaluation of the returned pod pc confirmed that the embolization coil was detached.Evaluation revealed that the pet lock was intact on the proximal end of the pusher assembly, the distal tip of the pusher assembly was fractured and the detached embolization coil was not returned for evaluation.The distal tip of pusher assembly may fracture if forcefully manipulated or retracted against resistance.The distal tip of the pusher assembly fracturing caused the embolization coil to detach.Based on the reported event, the root cause of resistance could not be determined.Further evaluation revealed a kink in the pusher assembly.This damage was incidental to the reported complaint and may have occurred during packaging of the device for return to penumbra.Penumbra coils 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using a pod packing coil (packing coil) and a lantern delivery microcatheter (lantern).During the procedure, the physician advanced the packing coil into the target location using the lantern; however, the packing coil was determined to be too long.Therefore, the physician decided to remove the packing coil.While retracting the packing coil, the coil unintentionally detached inside the lantern and partially in the hepatic artery.Therefore, the physician used a stent to secure the detached packing coil in the hepatic artery to prevent the packing coil from moving.It was reported that the physician did not initially attempt to remove the detached packing coil using a snare device due to the potential difficulty it could cause as the packing coil was partially within previously implanted coils.The procedure ended at this point.

• 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: 19131306
• Report Number: 3005168196-2024-00148
• Device Sequence Number: 17855870
• Product Code: HCG
• UDI-Device Identifier: 00814548017662
• UDI-Public: 814548017662
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K170852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2024
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: RBYPODJ45
• Device Lot Number: F111799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2024
• 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: 03/22/2024
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/31/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005