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

Catalog Number	RBY2C0430
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the coil.The ruby coil was kinked approximately 5.0 cm from the hub, bent approximately 15.0, 24.0, 49.0, 72.0, 80.0, and 118.5 cm from the hub, and fractured approximately from 116.5 cm from the hub.The embolization coil was detached from its pusher assembly.The embolization coil had offset coil winds and the proximal constraint sphere was intact with the coil.Coagulated blood was visible inside the introducer sheath.The ruby coil was damaged and the embolization coil was detached.Therefore, functional testing was unable to be performed.Conclusions: evaluation of the returned ruby coil revealed a damaged embolization coil, blood clotted inside the introducer sheath, and a fracture pusher assembly.If the introducer sheath is not properly aligned in the hub prior to advancement, offset coil winds may occur.These offset coil winds will likely contribute to the inability to advance the coil into the microcatheter.Further evaluation revealed clotted blood inside the sheath.If continuous flush is not used, blood may clot on the embolization coil and may contribute to the difficulty advancing the coil.Additional evaluation revealed a kink, bends, and a fracture along the length of the device.Based on the reported complaint, the kink, some of the bends, and the fracture may have occurred due to forcefully advancing and retracting the ruby coil against resistance.If the pusher assembly fractures, the pull wire is likely to be pulled from the distal detachment tip (ddt).If this occurs, the embolization coil will be detached from the pusher assembly.Based on the return condition, some of the bends are likely incidental to the reported complaint and may have occurred during packaging 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a gastrointestinal bleed using ruby coils.During the procedure, the physician felt resistance and was unable to advance a ruby coil into a lantern delivery microcatheter (lantern) and, therefore, the ruby coil was removed.The physician was able to advance the ruby coil out of the tip of its introducer sheath on the back table and then attempted to advance the ruby coil into the lantern again.However, the physician was unable to advance the ruby coil into the lantern again.Therefore, the procedure was completed using new coils and the same lantern.It was reported that the physician flushed the lantern between each attempt to advance the ruby coil.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7820448
• Report Number: 3005168196-2018-01691
• Device Sequence Number: 2433658
• Product Code: HCG
• UDI-Device Identifier: 00814548012872
• UDI-Public: 00814548012872
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/31/2018
• 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: 02/21/2026
• Device Catalogue Number: RBY2C0430
• Device Lot Number: F82040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 08/27/2018
• 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