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

Catalog Number	RBY2C0825
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery using pod coils, ruby coils and a lantern delivery microcatheter (lantern).During the procedure, while advancing a pod coil through the lantern, the hospital tech experienced resistance and kinked then fractured the pusher assembly of the pod coil.Therefore, the pod coil was removed.It was reported that the pod coil was intact and was connected to the fractured pusher assembly.It was reported that a second pod coil was unable to advance through the lantern and was removed.Next, while advancing a ruby coil through the lantern, the hospital technician experienced resistance.It was noted that a small section of ruby coil was outside of the lantern.The physician then decided to remove the ruby coil.While retracting the pusher wire, the physician noticed under fluoroscopy that the ruby coil was not moving and the ruby coil had fractured.Therefore, the guide catheter and lantern containing the ruby coil were removed.The procedure was completed with additional ruby coils and a new lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil could not confirm the reported fracture.Evaluation revealed that the embolization coil was intact with the pusher assembly and had offset coil winds.The offset coil winds is likely the reported damage.If the device is advanced against resistance during use, damage such as this may occur.During evaluation, the ruby coil was able to be advanced through a demonstration lantern with resistance due to the offset coil winds.Penumbra devices 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.Note: based on the investigation findings, this is not considered a reportable event.This event did not and, if it were to recur, it would not cause or contribute to serious deterioration or death.

• Brand Name: RUBY COIL
• 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: 19353363
• Report Number: 3005168196-2024-00195
• Device Sequence Number: 7724990
• Product Code: HCG
• UDI-Device Identifier: 00814548018850
• UDI-Public: 814548018850
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024
• 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: RBY2C0825
• Device Lot Number: F00010398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/25/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2024
• 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 Age: 74 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005