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

Model Number	RBY2C2457-B
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2020
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 internal iliac artery using ruby coils and a non-penumbra microcatheter.During the procedure, while advancing the ruby coil through the microcatheter, the physician encountered resistance, and the ruby coil became stuck.The physician then decided to remove it.While removing the ruby coil, it unintentionally detached inside the microcatheter; therefore, the microcatheter containing the detached ruby coil was removed, and the ruby coil was flushed out.The procedure was completed using two other ruby coils, eleven non-penumbra coils, and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pusher assembly was fractured on its proximal end.The total length of the pusher assembly was approximately 171.0 cm; therefore, approximately 5.0 cm of the pusher assembly was fractured and not returned for evaluation.The pull wire was also not returned for evaluation.The embolization coil was undamaged and detached from the pusher assembly.Conclusions: evaluation of the returned ruby coil confirmed a detached embolization coil and revealed a fractured pusher assembly.If the device is forcefully advanced against resistance or is otherwise mishandled at extreme angles during use, damage such as a kink and subsequent fracture may occur.If the pusher assembly fractures, the embolization coil will detach.The proximal fractured segment of the pusher assembly and the microcatheter identified in the procedure were not returned for evaluation; therefore, the root cause of resistance 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.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: 9913666
• Report Number: 3005168196-2020-00488
• Device Sequence Number: 16926918
• Product Code: HCG
• UDI-Device Identifier: 00814548019291
• UDI-Public: 00814548019291
• 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
• Report Date (Section B): 03/09/2020
• 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: RBY2C2457-B
• Device Catalogue Number: RBY2C2457
• Device Lot Number: F90506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 06/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Date Report Sent to FDA: 01/01/2005