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

Catalog Number	RBYPOD10
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	09/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using a pod coil and a non-penumbra microcatheter.It should be noted that the patient¿s anatomy was highly tortuous and moderately calcified.During the procedure, while advancing the pod coil, the physician felt resistance in the mid-shaft of the microcatheter.When attempting to retract the pod coil, the physician felt resistance and the pod coil unintentionally detached within the microcatheter at the mid-shaft.Therefore, the microcatheter containing the detached pod coil was removed.The pod coil was then flushed out of the microcatheter on the back table.The procedure was completed using nine ruby coils, one pod packing coil (packing coil), ten non-penumbra coils, and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: POD 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: 20859767
• Report Number: 3005168196-2024-00401
• Device Sequence Number: 14470559
• Product Code: HCG
• UDI-Device Identifier: 00814548019659
• UDI-Public: 00814548019659
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/05/2024

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: RBYPOD10
• Device Lot Number: F00010014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/26/2023
• 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