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

Model Number	RBY4C0315-A
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
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 in the obturator artery (oa) using a ruby coil and non-penumbra microcatheter.During the procedure, while advancing the ruby coil out of the microcatheter, the microcatheter kicked back.Therefore, the physician removed the ruby coil from the patient and repositioned the microcatheter.The physician attempted to advance the ruby coil again and the same issue occurred.The physician made a third attempt to place the ruby coil; however, resistance was experienced and the ruby coil would not advance further into the microcatheter and got stuck.Therefore, the physician decided to remove the microcatheter and ruby coil.The procedure was completed using another ruby coil and a new microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil pusher assembly revealed that the embolization coil was detached from the pusher assembly due to a fractured sr wire.If the ruby coil is forcefully retracted against resistance, damage such as sr wire fracture may occur, and the embolization coil may detach from the pusher assembly.The detached embolization coil was not returned for evaluation.The root cause of the resistance experienced during the procedure 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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11905881
• Report Number: 3005168196-2021-01190
• Device Sequence Number: 3241970
• Product Code: HCG
• UDI-Device Identifier: 00814548013152
• UDI-Public: 00814548013152
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2021
• 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: RBY4C0315-A
• Device Catalogue Number: RBY4C0315-A
• Device Lot Number: F101624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 05/30/2021
• Supplement Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Date Report Sent to FDA: 01/01/2005