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

Model Number	RBY2C0840-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	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 in the splenic artery using a lantern delivery microcatheter (lantern) and a ruby coil.During the procedure, the physician placed two ruby coils into the target vessel using the lantern.Next, the physician advanced a third ruby coil into the target vessel; however, the physician was not satisfied with the placement of the ruby coil.While retracting the ruby coil to reposition it, the physician experienced resistance and subsequently, the ruby coil became stuck.Therefore, the physician removed the lantern containing the ruby coil and then removed the ruby coil.The procedure was completed using six additional penumbra coils and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This report is associated with mfr report number: 3005168196-2021-02194.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using a lantern delivery microcatheter (lantern) and a ruby coil.During the procedure, the physician placed two ruby coils into the target vessel using the lantern.Next, the physician advanced a third ruby coil into the target vessel; however, the physician was not satisfied with the placement of the ruby coil.While retracting the ruby coil to reposition it, the physician experienced resistance and subsequently, the ruby coil became stuck.Therefore, the physician removed the lantern containing the ruby coil.The procedure was completed using six additional penumbra coils and a non-penumbra microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil revealed that the embolization coil was detached from its pusher assembly due to a pusher assembly fracture.If the ruby coil is forcefully manipulated against resistance, the pusher assembly may become kinked and may subsequently fracture.Further evaluation of the returned ruby coil revealed kinks in the pusher assembly.This damage was likely incidental to the reported complaint.The returned device was unable to be tested for the reported issue due to being detached.The root cause of the reported event could not be determined.A demonstration coil was advanced through the non-penumbra microcatheter without an issue.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.The investigation findings do not lead to a clear conclusion about the root cause of resistance and ruby coil becoming stuck.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11089558
• Report Number: 3005168196-2020-02375
• Device Sequence Number: 11027786
• Product Code: HCG
• UDI-Device Identifier: 00814548012988
• UDI-Public: 00814548012988
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2021
• 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: RBY2C0840-A
• Device Catalogue Number: RBY2C0840
• Device Lot Number: F99228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 03/29/2021; 01/14/2005
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 04/27/2021; 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 84
• Date Report Sent to FDA: 01/01/2005