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

Catalog Number	RBYPODJ30
Medical Device Problem Codes	Failure to Fold (1255); Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right renal artery using ruby coils, pod packing coils (packing coil), non-penumbra coils, a non-penumbra microcatheter, a non-penumbra sheath, and a guidewire.During the procedure, the physician placed multiple ruby coils, packing coils, and non-penumbra coils in the aneurysm using the microcatheter.While advancing the next packing coil into the target location, the physician noticed that the packing coil was not forming its intended shape and remained straight.The physician attempted to retract the packing coil, but experienced resistance and the packing coil had fractured.It was reported that the physician was able to successfully remove the proximal fractured portion of the packing coil out from the microcatheter.The physician then injected saline to push the distal fractured portion of the packing coil into the aneurysm and determined that the packing coil was safely implanted.The procedure was completed using additional coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Evaluation of the returned pod packing coil (packing coil) confirmed that the pusher assembly was fractured, and the embolization coil was detached from the pusher assembly.If the packing coil is retracted against resistance at an angle, damage such as a kink and subsequent fracture on the pusher assembly may occur.The pull wire was retracted out at the fractured location and likely caused the embolization coil detachment during the procedure.The embolization coil was implanted during the procedure; therefore, was not returned for evaluation.Based on the reported event, the root cause of the resistance could not be determined.Further evaluation of the device revealed an additional fracture and kinks on the pusher assembly.Based on the reported event, this damage was incidental to the complaint and likely occurred during packaging 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.

• Brand Name: POD PACKING COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 20870071
• Report Number: 3005168196-2024-00408
• Device Sequence Number: 20980463
• Product Code: HCG
• UDI-Device Identifier: 00814548017655
• UDI-Public: 00814548017655
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K170852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2025

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: F00008979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 02/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2024
• 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 Age: 68 YR
• Patient Sex: Male
• Patient Weight: 91 KG