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

Catalog Number RBYPOD3

Device Problem Break (1069)

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

Event Date 09/20/2022

Event Type  malfunction  

Event Description

The patient was undergoing a coil embolization procedure in the left femoral vein using a pod packing coil (pod pc), a pod coil, and a lantern delivery microcatheter (lantern).During the procedure, after advancing approximately half of the pod pc in the lantern, the pod pc became stuck.Therefore, the lantern containing the pod pc was removed.The pod pc was then removed from the lantern and the lantern was reinserted into the patient.Afterwards, while advancing the pod coil through the lantern, the physician broke the pusher assembly of the pod coil.It was reported that the embolization coil was still attached to the pusher assembly.Therefore, the lantern containing the pod coil was removed.The procedure was completed using new pod pcs, and the same lantern.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: 15664541
• MDR Text Key: 302851414
• Report Number: 3005168196-2022-00494
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548019581
• UDI-Public: 814548019581
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K173614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBYPOD3
• Device Lot Number: F104763
• 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
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2021
• 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: 23 YR
• Patient Sex: Male