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

Model Number	RBY2C1660-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	02/11/2020
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 left renal artery using ruby coils and non-penumbra microcatheter.During the procedure, while advancing a ruby coil through the microcatheter, the physician experienced resistance and, subsequently, the ruby coil unintentionally detached inside of the microcatheter.Therefore, the physician pulled the detached ruby coil out from the microcatheter and successfully removed the coil.The procedure was completed using a new ruby coil and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked at approximately 76.0 cm from the proximal end.The pusher assembly was fractured approximately 77.0 cm from the proximal end.The pull wire was retracted from the pusher assembly distal detachment tip (ddt) and the embolization coil was detached from the pusher assembly.The proximal constraint sphere was intact with the embolization coil and embolization coil had offset coil winds.Conclusions: evaluation of the returned ruby coil revealed a kink and a fracture on its pusher assembly, and offset coil winds along the length of its embolization coil.If the device is forcefully advanced against resistance, damages such as these may occur.The non-penumbra microcatheter used in the procedure was not returned for evaluation; therefore, the root cause of the resistance experienced during the procedure could not be determined.Further evaluation of the device revealed that the pull wire was retracted from the pusher assembly ddt and the embolization coil was detached from the pusher assembly.These damages likely occurred due to the pusher assembly fracture.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.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: 9795587
• Report Number: 3005168196-2020-00308
• Device Sequence Number: 2574217
• Product Code: HCG
• UDI-Device Identifier: 00814548013053
• UDI-Public: 00814548013053
• Combination Product (Y/N): Y
• Initial Reporter Country: SN
• 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
• Report Date (Section B): 02/11/2020
• 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 Model Number: RBY2C1660-A
• Device Catalogue Number: RBY2C1660
• Device Lot Number: F93622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Date Report Sent to FDA: 01/01/2005