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

Catalog Number RBYPOD8

Device Problems Break (1069); Material Deformation (2976); Physical Resistance/Sticking (4012)

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

Event Date 07/21/2022

Event Type  malfunction  

Event Description

The patient was undergoing a coil embolization procedure in the left hypogastric artery using a pod coil and a non-penumbra microcatheter.During the procedure, the physician was experiencing resistance while advancing the pod coil through the microcatheter.After approximately 10 centimeters of the pod coil was advanced distally into the vessel, the physician kinked and broke the pusher assembly.Consequently, the pod coil detached inside the microcatheter.Therefore, the microcatheter containing the detached pod coil was removed and the coil was flushed out on the back table.The procedure was completed using a new pod coil, a pod packing coil (pod pc), three ruby coils, and the same microcatheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Additional device code that also applies to this complaint: (b)(4).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: 15222669
• MDR Text Key: 305189794
• Report Number: 3005168196-2022-00374
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548019635
• UDI-Public: 814548019635
• 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: 01/01/2005,08/13/2022

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: RBYPOD8
• Device Lot Number: F114024
• 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: 07/21/2022
• Initial Date FDA Received: 08/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2022
• 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: 87 YR
• Patient Sex: Male