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

Catalog Number RBYPOD10

Device Problems Material Deformation (2976); Premature Separation (4045)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2024

Event Type  malfunction  

Event Description

The patient was undergoing a coil embolization procedure using a pod coil and a non-penumbra microcatheter.During the procedure, while advancing the pod coil through the microcatheter, the physician kinked the pusher assembly and the pod coil had unintentionally detached inside the microcatheter.It was reported that the detached pod coil was contained inside the microcatheter.Therefore, the physician was able to pull and remove the detached pod coil out from the microcatheter.The procedure was completed using a new pod coil and the same microcatheter.There was no report of an adverse effect to the patient.

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
• Type of Device: 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: 18821024
• MDR Text Key: 337735301
• Report Number: 3005168196-2024-00069
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,03/01/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: RBYPOD10
• Device Lot Number: F00005930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR