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

Catalog Number	RBY2C1660
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the second ruby coil evaluated.The pusher assembly was kinked in multiple locations from the proximal end.The embolization coil was intact with its pusher assembly.The introducer sheath was ovalized approximately 7.0 cm from the distal tip and the sheath had coagulated blood inside.Resistance was encountered while attempting to advance the ruby coil out of its introducer sheath.Conclusions: evaluation of the first returned ruby coil revealed that the pusher assembly was kinked and the coil winds were offset.If the device is forcefully advanced against resistance, damage such as a kink may occur.Further evaluation of the returned device revealed that the embolization coil winds were offset.This damage was likely incidental and may have occurred due to the embolization coil not being protected by its introducer sheath, while packaging the device for return to penumbra.Evaluation of the second returned ruby coil revealed that the introducer sheath was ovalized.If the rotating hemostasis valve (rhv) is overtightened on the introducer sheath prior to advancing the coil into a microcatheter, resistance may be encountered and damage such as a pusher assembly kink may result.Further evaluation revealed multiple kinks along the length of the pusher assembly.Some of these kinks may have been due to forceful advancement against resistance, while some of them were likely incidental and may have occurred due to packaging of the device for return to penumbra.Evaluation of the third returned ruby coil revealed that the coil was knotted out of the distal tip of the sheath and the sr wire was fractured.If the embolization coil becomes tangled outside of the microcatheter, damage such as a knot may occur.Subsequently, if the knotted coil is attempted to be retracted introducer sheath, damage such as a fractured sr wire may result.Further evaluation of the ruby coil revealed that the pusher assembly was kinked in multiple locations.If the device is forcefully advanced against resistance, damage such as a kink may occur.Some of these kinks were likely incidental to the reported issue and likely occurred due to packaging of the device for return to penumbra.The lantern identified in the complaint was not returned to penumbra for evaluation.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.This report is associated with mfr report number: 3005168196-2018-01502, 3005168196-2018-01504.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal illiac artery (iia) using ruby coils.During the procedure, while attempting to advance a ruby coil into a lantern delivery microcatheter (lantern) the physician experienced resistance and, consequently, the ruby coil pusher wire became kinked; therefore, it was removed.It was reported that the same issue occurred with two other ruby coil.The procedure was completed using a new ruby coil and the same lantern.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: 7747717
• Report Number: 3005168196-2018-01503
• Device Sequence Number: 1794244
• Product Code: HCG
• UDI-Device Identifier: 00814548013053
• UDI-Public: 00814548013053
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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): 07/05/2018
• 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: 11/09/2024
• Device Catalogue Number: RBY2C1660
• Device Lot Number: F72838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• 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: 07/05/2018
• Initial Report FDA Received Date: 08/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 91
• Date Report Sent to FDA: 01/01/2005