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

Catalog Number	RBY4C2060
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	12/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly had bends at approximately 43.0 cm and 91.0 cm from the proximal end.The smart coil pusher assembly mid-joint was proximal to the introducer sheath friction lock.The embolization coil was intact with the distal tip of the pusher assembly and coil was undamaged.Conclusions: evaluation of the returned ruby coil revealed the pusher assembly mid-joint retracted through the introducer sheath friction lock.The introducer sheath friction lock inner diameter (id) is smaller than the id of the rest of the sheath to allow it to properly seat on the pusher assembly mid-joint.If the pusher assembly mid-joint is retracted through the introducer sheath friction lock, resistance may be experienced when attempting to advance the device.Further evaluation revealed bends along the length of the pusher assembly.These bends were likely incidental to the complaint and may have occurred during packaging for return to penumbra.During functional testing, the ruby coil was able to advance through its introducer sheath and a demonstration lantern delivery microcatheter with moderate resistance experienced when the bends contacted and were advanced through the introducer sheath and microcatheter.Penumbra coils are 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 in the thoracic aorta using ruby coils.During the procedure, the physician successfully placed several coils in the target vessel using a lantern delivery microcatheter (lantern).While attempting to advance a ruby coil, the physician experienced resistance and was unable to advance the ruby coil from its initial position in the introducer sheath; therefore, the ruby coil was removed.The procedure was completed using a new ruby coil and other coils with 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: 8279000
• Report Number: 3005168196-2019-00149
• Device Sequence Number: 19357869
• Product Code: HCG
• UDI-Device Identifier: 00814548019123
• UDI-Public: 00814548019123
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• 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
• Report Date (Section B): 12/26/2018
• 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: 07/16/2026
• Device Catalogue Number: RBY4C2060
• Device Lot Number: F84726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• 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: 12/26/2018
• Initial Report FDA Received Date: 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 68
• Date Report Sent to FDA: 01/01/2005