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

Catalog Number	RBYPOD10
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned pod coil confirmed that the embolization coil was detached from the pusher assembly.Further evaluation revealed that the pull wire was inside the pusher assembly ddt, the proximal constraint sphere was within the ddt, and the sr component was fractured.If the device is retracted against resistance, damage such as an sr component fracture may occur.This likely contributed to the detached embolization coil.Further evaluation also revealed offset coil winds on the embolization coil, and the sr component was fractured within the embolization coil.The root cause of this damage could not be determined; however, the cause of this damage may have contributed to resistance during retraction.Penumbra coils are 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 or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using pod coils, a lantern delivery microcatheter (lantern), an angiographic catheter, and a non-penumbra guide sheath.It should be noted that the patient's anatomy was tortuous.During the procedure, the physician implanted an embolic device into the target location.Next, the physician began to embolize another part of the target vessel with a pod coil, three non-penumbra coils, and two pod packing coils (pod pcs).After advancing another pod coil into the target location, the coil unintentionally detached when it was advanced approximately one third of the way outside of the lantern.Therefore, the physician removed the detached pod coil by pinching the guide sheath with forceps and removing the guide sheath, lantern, and pod coil together from the patient.The procedure was completed using a stent graft without additional coil embolization.There was no report of an adverse effect to the patient.

• Brand Name: POD
• Common Device Name: 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: 15829865
• Report Number: 3005168196-2022-00544
• Device Sequence Number: 5250496
• Product Code: HCG
• UDI-Device Identifier: 00814548019659
• UDI-Public: 814548019659
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/18/2022
• Report Date (Section F): 01/01/2005

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: F00000305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 11/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2022
• 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: Female
• Date Report Sent to FDA: 01/01/2005