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

Model Number	RBYPOD5-A
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned pod coil revealed that the ddt was fractured off the distal tip of pusher assembly and the embolization coil was detached.If the pod coil is forcefully mishandled against resistance during use, damage such as a fracture may occur and result in the embolization coil detachment.Based on the returned condition, the root cause of the reported resistance could not be determined.Further evaluation revealed kinks in the pusher assembly.This damage was incidental to the reported complaint and the root cause could not be determined.Penumbra coils are visually inspected during in-process inspection and during 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 pulmonary artery using a pod coil and a lantern delivery microcatheter (lantern).During the procedure, the physician advanced a pod coil into the target location using the lantern.The physician then experienced resistance after forming one loop with the pod coil into the target location.Subsequently, while forming approximately four loops with the pod coil, the physician felt as if the pod coil had detached.Therefore, the physician decided to retract the pod coil.However, while attempting to retract the pod coil, the physician noticed that the pod coil had unintentionally detached inside the lantern.Therefore, the physician removed the lantern containing the detached pod coil from the patient and then removed the pod coil from the lantern on the back table.The procedure was completed using four ruby coils, five pod packing coils (pod pcs), and the same lantern.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
• MDR Report Key: 12422176
• Report Number: 3005168196-2021-01956
• Device Sequence Number: 3516275
• Product Code: HCG
• UDI-Device Identifier: 00814548019604
• UDI-Public: 00814548019604
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/03/2021
• 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 Model Number: RBYPOD5-A
• Device Catalogue Number: RBYPOD5
• Device Lot Number: F101846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• 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: 08/12/2021
• Initial Report FDA Received Date: 09/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 7 YR
• Patient Weight: 22
• Date Report Sent to FDA: 01/01/2005