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

Model Number RBYPODJ30-A

Device Problems Break (1069); Failure to Fold (1255)

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

Event Date 12/28/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the returned pod packing coil could not confirm that the embolization coil fractured during the procedure.Evaluation revealed that the distal tip of the embolization coil was present.This indicates that none of the embolization coil was left in the vessel as mentioned in the complaint.Therefore, the root cause of the reported complaint could not be determined.Further evaluation revealed pusher assembly kinks throughout its length, and offset coil winds throughout the length of the embolization coil.The offset coil winds may have prevented the embolization coil from taking shape in vessel during the procedure.The pusher assembly kinks were incidental to the reported complaint and may have occurred during packaging for return.Due to the returned condition, the pod packing coil could not be functionally tested.Penumbra coils 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 Description

The patient was undergoing a coil embolization procedure in the iliolumbar artery using pod packing coils (pod pcs), ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician placed several ruby coils and pod pcs in the target location using the lantern.While attempting to place the next pod pc into the target vessel, the pod pc would not form initially and stayed straight before starting to form.While continuing to advance the pod pc, the embolization coil broke.It was reported that the physician was able to remove approximately 10 cm of the coil by retracting the pusher assembly and the remaining 20 cm of the pod pc was left in the patient¿s vessel.The procedure was completed by using additional coils and the same lantern.There was no report of an adverse effect to the patient.

• Brand Name: POD PACKING COIL
• 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: 13338169
• MDR Text Key: 287420764
• Report Number: 3005168196-2022-00022
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548017655
• UDI-Public: 00814548017655
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170852
• 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: 01/01/2005,01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RBYPODJ30-A
• Device Catalogue Number: RBYPODJ30
• Device Lot Number: F92770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• 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: 12/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2019
• 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
• Patient Sex: Male