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

Catalog Number	RBYPODJ5
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	03/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was implanted in the patient; therefore, a device investigation could not be performed.Without the return of the device, the root cause of the problem could not be determined.The manufacturing records for the lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 1.3005168196-2024-00174.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the common iliac artery (cia) using a lantern delivery microcatheter (lantern), ruby coils, pod packing coils (packing coils), a non-penumbra catheter, and a guidewire.During the procedure, while advancing the lantern through the catheter, the physician experienced resistance and fractured the midshaft of the lantern in multiple places.Therefore, the physician removed the catheter containing the fractured lantern.The physician then implanted three ruby coils in the target location using a new lantern.The physician then flushed the lantern.While advancing a packing coil through the lantern and into the target location, the physician experienced resistance and the packing coil unintentionally detached within the lantern.The physician then used another packing coil to push the detached packing coil into the target location.The procedure was completed after placing the packing coil using the second lantern and the same catheter.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: 19250859
• Report Number: 3005168196-2024-00175
• Device Sequence Number: 17789611
• Product Code: HCG
• UDI-Device Identifier: 00814548017631
• UDI-Public: 814548017631
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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
• Report Date (Section B): 05/06/2024
• 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: RBYPODJ5
• Device Lot Number: F112099
• Was Device Available for Evaluation?: No
• 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: 04/08/2024
• Initial Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2022
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Date Report Sent to FDA: 01/01/2005