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

Model Number	RBY4C0406-A
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.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 a branch of the splenic artery using ruby coils and a non-penumbra microcatheter.During the procedure, the physician encountered resistance while advancing the ruby coil midway through the microcatheter, which was inside the patient.Therefore, the ruby coil was removed.The procedure was completed using another ruby coil and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil revealed that the pull wire was advanced distal to its initial position within the pusher assembly ddt alignment feature.If the device is forcefully advanced against resistance, damage such as this may occur.The root cause of initial resistance during the procedure could not be determined.Further evaluation revealed that the embolization coil had offset coil winds and was detached from its pusher assembly due to a fractured sr wire.This damage was likely incidental to the reported complaint and may have occurred after removal of the device from the procedure.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.H.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the cause of the resistance experienced during the procedure.H3 other text : placeholder.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10844256
• Report Number: 3005168196-2020-02005
• Device Sequence Number: 11673773
• Product Code: HCG
• UDI-Device Identifier: 00814548013169
• UDI-Public: 00814548013169
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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): 10/23/2020
• 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: 02/21/2026
• Device Model Number: RBY4C0406-A
• Device Catalogue Number: RBY4C0406
• Device Lot Number: F82031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005