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

Model Number	RBY2C1240-B
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the ruby coil was stuck inside the lantern.Therefore, the lantern and ruby coil could not be functionally tested.Conclusions: evaluation of the returned lantern revealed that the distal of the catheter was ovalized.If the peel-able sheath (supplied by penumbra) is not used during insertion of the lantern into a parent device, damage such as ovalization may occur.Further evaluation of the returned lantern revealed that the ruby coil was stuck inside the ovalized distal tip of the lantern.If the ruby coil is advanced through a damage catheter, resistance maybe encountered, subsequently, if the ruby coil is forcefully retracted against resistance, damage such as the ruby coil detaching inside the lantern may occur.The root cause as to how the ruby coil detached from its pusher could not be determined.The ruby coil pusher assembly was not returned to penumbra for evaluation.Penumbra coils and catheters 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.This report is associated with mfr report number: 3005168196-2018-01971.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, the physician felt resistance while advancing a ruby coil out of the tip of a lantern delivery microcatheter (lantern) and, consequently, the ruby coil unintentionally detached within the lantern.The physician, therefore, removed the lantern with the ruby coil inside.The procedure was completed using a new microcatheter and additional ruby coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The investigation findings do not lead to a clear conclusion about the root cause of the unintentional detachment.This report is associated with mfr report number: 3005168196-2018-01971.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7936830
• Report Number: 3005168196-2018-01972
• Device Sequence Number: 13685484
• Product Code: HCG
• UDI-Device Identifier: 00814548019086
• UDI-Public: 00814548019086
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• 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): 09/07/2018
• 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: 05/02/2026
• Device Model Number: RBY2C1240-B
• Device Catalogue Number: RBY2C1240
• Device Lot Number: F83224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/07/2018
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 07/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Date Report Sent to FDA: 01/01/2005