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

Catalog Number	RBYPODJ5
Medical Device Problem Codes	Material Deformation (2976); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned pod pc confirmed that the pusher assembly was fractured.If the pod pc is advanced at an extreme angle during use, damage such as a kink on the pusher assembly may occur.Further manipulation of the kinked pusher assembly may have worsened to a fracture.If the pusher assembly becomes fractured, the embolization coil will likely detach.The fractured pusher assembly likely contributed to the embolization coil detachment during the procedure.The detached embolization coil was not returned for evaluation.Penumbra products 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 splenic artery using pod packing coil (pod pcs) and a non-penumbra microcatheter.During the procedure, while advancing the pod pc out from the introducer sheath and into the microcatheter, the physician noticed the proximal end of the pusher assembly was bent.Therefore, the physician decided to remove the pod pc.However, while removing the coil, the pusher assembly of the pod pc broke and a portion of the pusher assembly with the inner filament wire came out.Consequently, the pod pc had unintentionally detached inside the microcatheter.Therefore, the physician injected saline to push the detached pod pc out of the microcatheter and into the vessel.The procedure was completed using an additional pod pc and the same microcatheter.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: 15730522
• Report Number: 3005168196-2022-00515
• Device Sequence Number: 2995627
• Product Code: HCG
• UDI-Device Identifier: 00814548017631
• UDI-Public: 814548017631
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K170852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/03/2022
• 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: F00000104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2022
• 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: 10/21/2022
• Initial Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2022
• 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: 38 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005