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

Model Number	RBY2C1460-B
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2019
Type of Reportable Event	Serious Injury
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 superior mesenteric artery (sma) aneurysm using ruby coils.During the procedure, the physician advanced lantern delivery microcatheter (lantern) and placed four ruby coils.During the placement of fifth ruby coil, the coil unintentionally detached in the vessel.Therefore, the physician removed the lantern and used a snare device to remove the detached ruby coil.The procedure was completed using a new guide catheter, the same lantern and three additional ruby coils.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 its pusher assembly.The pusher assembly was kinked approximately 1.5, 23.0, 44.0, and 99.0 cm from its proximal end.The embolization coil was detached from its pusher assembly.The non-penumbra guide catheter was ovalized approximately 29.0 cm from its hub.Conclusions: evaluation of the returned ruby coil confirmed that the embolization coil was detached from its pusher assembly.If the ruby coil is forcefully retracted against resistance, the polymer section of the pusher assembly may elongate and allow the embolization coil to detach from its pusher assembly.The lantern identified in the complaint was not returned for evaluation and, therefore, the root cause of resistance could not be determined.Further evaluation of the returned ruby coil revealed kinks in the pusher assembly.These kinks were likely incidental to the reported complaint.Evaluation of the non-penumbra guide catheter revealed ovalization along the catheter shaft.The root cause of this damage could not be determined.This ovalization would likely contribute to resistance during delivery of a ruby coil.During functional testing, resistance was experienced while attempting to advance a demonstration lantern pass the ovalization in the non-penumbra guide catheter, and the coil could not be advanced any further.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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9439036
• Report Number: 3005168196-2019-02275
• Device Sequence Number: 3282444
• Product Code: HCG
• UDI-Device Identifier: 00814548019116
• UDI-Public: 00814548019116
• 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): 11/12/2019
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RBY2C1460-B
• Device Catalogue Number: RBY2C1460
• Device Lot Number: F87015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 03/02/2020
• 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