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

Catalog Number	RBY2C1857
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/29/2019
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat varices using ruby coils.During the procedure, while attempting to advance a ruby coil out of its introducer sheath and into a non-penumbra microcatheter, the hospital technologist experienced difficulty and stopped immediately pushing the ruby coil.Therefore, the ruby coil was retracted back into its introducer sheath and the microcatheter flushed.A second attempt was then made and the same issue occurred.It was reported that the ruby coil was advanced approximately five to ten centimeters within its introducer sheath then it became difficult to push; therefore, it was removed.The procedure was completed using another ruby coil and the same microcatheter.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pusher assembly.The pusher assembly was kinked in multiple locations.The pusher assembly distal detachment tip (ddt) was retracted proximal to the introducer sheath friction lock.The embolization coil was intact with its pusher assembly.Conclusions: evaluation of the returned ruby coil revealed that the pusher assembly ddt was retracted proximal to the introducer sheath friction lock.If the pusher assembly ddt is retracted proximal to the introducer sheath friction lock, it may become difficult to advance the coil through its introducer sheath and into a microcatheter.The introduce sheath has a smaller inner diameter (id) than the pusher assembly mid-joint.This allows the introducer sheath to seat properly on the pusher assembly mid-joint.Further evaluation of the returned ruby coil revealed that the pusher assembly was kinked in multiple locations.These kinks were likely incidental to the reported complaint 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: 8649590
• Report Number: 3005168196-2019-01044
• Device Sequence Number: 2340443
• Product Code: HCG
• UDI-Device Identifier: 00814548019260
• UDI-Public: 00814548019260
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 04/29/2019
• 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: 08/25/2026
• Device Catalogue Number: RBY2C1857
• Device Lot Number: F85461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 08/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005