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

Catalog Number	RBY4C0202
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2019-00533.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right circumflex artery in the arm using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician accessed the target vessel via the femoral artery on the right side, and attempted to detach the first ruby coil.However, the ruby coil and lantern together kicked back out of the target vessel and slipped out.In order to begin repositioning the lantern and re-gain access to the target vessel, the technician first began resheathing the ruby coil.While retracting through the microcatheter, the ruby coil detached from its pusher wire and became lodged in the rhv.It was also noted that the technician was wrapping the ruby coil wire in a loop while retracting.The ruby coil was then removed and the rhv was flushed.The procedure was completed using a penumbra coil of the same size, two additional coils, the same catheter, and the same lantern.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 approximately 5.0 and 14.0 cm from the proximal end.The embolization coil was detached from its pusher assembly and the pull wire remained intact with the distal detachment tip (ddt).The embolization coil had offset and compressed coil winds.Conclusions: evaluation of the returned ruby coil revealed that the embolization coil had offset and compressed coil winds and was detached from its pusher assembly.If the rotating hemostasis valve (rhv) is overtightened during use and not loosened prior to re-sheathing the coil, damage such as this may occur.Further evaluation of the returned ruby coil revealed that the pusher assembly was kinked.These kinks were likely incidental to the reported issue and may have occurred from packaging the device for return to penumbra.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: 8445022
• Report Number: 3005168196-2019-00534
• Device Sequence Number: 14197588
• Product Code: HCG
• UDI-Device Identifier: 00814548018263
• UDI-Public: 00814548018263
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2019
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/15/2026
• Device Catalogue Number: RBY4C0202
• Device Lot Number: F85868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/21/2019
• Supplement Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 05/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Date Report Sent to FDA: 01/01/2005