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

Model Number	RBY2C2457-A
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	03/11/2020
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 ruby coils and a non-penumbra microcatheter.During the procedure, the physician encountered resistance while advancing a ruby coil through the proximal end of the microcatheter, where it subsequently became stuck and detached.Therefore, the ruby coil was removed from the microcatheter.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
Results: the embolization coil was detached from the pusher assembly and had offset coil winds along its length.The proximal constraint sphere was intact with the embolization coil.Conclusions: evaluation of the returned ruby coil confirmed that the embolization coil was detached from the pusher assembly.Further evaluation revealed offset coil winds along the embolization coil.If the device is forcefully advanced against resistance, damage such as offset coil winds may occur.The pusher assembly and the non-penumbra microcatheter used in the procedure were not returned for evaluation; therefore, the root cause of the resistance experienced during the procedure and the detached embolization coil were unable to 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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the reported resistance experienced during the procedure and the detached embolization coil.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9926184
• Report Number: 3005168196-2020-00515
• Device Sequence Number: 3296752
• Product Code: HCG
• UDI-Device Identifier: 00814548013084
• UDI-Public: 00814548013084
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2020
• 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: 09/30/2022
• Device Model Number: RBY2C2457-A
• Device Catalogue Number: RBY2C2457
• Device Lot Number: F60677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 04/04/2020
• Supplement Report FDA Received Date: 05/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 70
• Date Report Sent to FDA: 01/01/2005