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

Model Number	RBY2C0320-B
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2020
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 in gastroduodenal artery (gda) using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, while introducing the ruby coil to the lantern, the pusher assembly became kinked.Therefore, the ruby coil was removed.The procedure was completed using another ruby coil 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 53.5 cm from the proximal end.The embolization coil was intact with the pusher assembly and had offset coil winds.Conclusions: evaluation of the returned ruby coil confirmed a pusher assembly kink.If the device is advanced against resistance or is otherwise mishandled at extreme angles during use, damage such as a kink may occur.Further evaluation revealed that the ruby coil was returned without its introducer sheath and offset coil winds on the embolization coil.During functional testing, the ruby coil was re-sheathed with a demonstration introducer sheath.Subsequently, the ruby coil was advanced through the introducer sheath and a demonstration lantern without an issue.The offset coil winds on the embolization coil may be incidental to the complaint.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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10368716
• Report Number: 3005168196-2020-01100
• Device Sequence Number: 16381488
• Product Code: HCG
• UDI-Device Identifier: 00814548018560
• UDI-Public: 00814548018560
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 07/16/2020
• 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 Model Number: RBY2C0320-B
• Device Catalogue Number: RBY2C0320
• Device Lot Number: F95736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 09/09/2020
• 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