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

Model Number	RBY2C2060-B
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2019
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.This report is associated with mfr report number: 3005168196-2020-00013.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using ruby coils and a lantern delivery microcatheter (lantern).It was noted that the patient's anatomy was slightly tortuous and calcified.During the procedure, a ruby coil was advanced into the lantern and became stuck.The ruby coil was then removed.Another ruby coil was then advanced into lantern and became stuck in the same location.This ruby coil was also removed.The procedure was completed using eleven ruby coils and the same lantern.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using ruby coils and a lantern delivery microcatheter (lantern).It was noted that the patient's anatomy was slightly tortuous and calcified.During the procedure, a ruby coil was advanced into the lantern and became stuck.The ruby coil was then removed.Another ruby coil was then advanced into lantern and the same issue occurred.This ruby coil was also removed.The procedure was completed using eleven other penumbra coils using the same lantern.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 distributor on 01/07/2020: 1.Section b.Box 5.Describe event or problem.2.Section d.Box 10.Device available for evaluation? 3.Section d.Box 10.Returned to manufacturer on.4.Section h.Box 3.Device returned to manufacturer? 5.Section h.Box 3.Device evaluated by manufacturer? 6.Section h.Box 6.Results codes.7.Section h.Box 6.Conclusions code.H3 other text : placeholder.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked at approximately 64.0 cm and 66.0 cm from the proximal end.The embolization coil was undamaged and intact with the pusher assembly.The introducer sheath was not returned for evaluation.Conclusions: evaluation of the returned ruby coils revealed undamaged and functional devices.During functional testing, both ruby coils were able to advance through a demonstration lantern without issue.The lantern used in the procedure was not returned for evaluation; therefore, the reported complaint could not be determined.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.This report is associated with mfr report number: 3005168196-2020-00013.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9560018
• Report Number: 3005168196-2020-00014
• Device Sequence Number: 2282535
• Product Code: HCG
• UDI-Device Identifier: 00814548019284
• UDI-Public: 00814548019284
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2019
• 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: RBY2C2060-B
• Device Catalogue Number: RBY2C2060
• Device Lot Number: F90760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 01/07/2020; 02/21/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 01/30/2020; 03/04/2020
• 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