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

Model Number	RBY4C0860-A
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure using a ruby coil and a lantern delivery microcatheter (lantern).During the procedure, while advancing a ruby coil approximately ten centimeters through the lantern, the physician experienced resistance and subsequently, the ruby coil became stuck.Then, the physician decided to remove the ruby coil.Upon retraction, the ruby coil unintentionally detached inside the lantern.It is unknown how the procedure was completed.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections are being updated based on additional information provided by a penumbra sales representative on 01/11/2021: 1.Section b.Box 5.Describe event or problem.Evaluation of the returned ruby coil confirmed that the embolization coil was detached from its pusher assembly.Further evaluation of the returned ruby coil revealed that the sr wire was fractured.If the ruby coil is forcefully retracted against resistance, the sr wire may fracture, causing the embolization coil to detach.The root cause of resistance could not be determined.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.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using a ruby coil and a lantern delivery microcatheter (lantern).During the procedure, while advancing a ruby coil approximately ten centimeters through the lantern, the physician experienced resistance and subsequently, the ruby coil became stuck.Therefore, the physician retracted the ruby coil into its introducer sheath and put the ruby coil in water.Later, the physician attempted to re-use the ruby coil and while attempting to advance the ruby coil, the physician experienced resistance.Subsequently, it was noticed that the ruby coil had detached from its pusher assembly outside the patient.Therefore, the physician removed the ruby coil and it was not used for the remainder of the procedure.The procedure was completed using additional ruby coils and the same lantern.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11099220
• Report Number: 3005168196-2020-02388
• Device Sequence Number: 17085711
• Product Code: HCG
• UDI-Device Identifier: 00814548013213
• UDI-Public: 00814548013213
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2020
• 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 Expiration Date: 04/08/2026
• Device Model Number: RBY4C0860-A
• Device Catalogue Number: RBY4C0860
• Device Lot Number: C22421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005