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

Model Number	RBY4C0202-B
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2020
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 coil a embolization procedure in the distal superior mesenteric artery (sma) using ruby coils, a ruby coil detachment handle (handle) and a non-penumbra microcatheter.During the procedure, the physician advanced a ruby coil into the target vessel using the microcatheter and attempted to detach it using the handle; however, the ruby coil failed to detach.Therefore, the ruby coil was removed.The procedure was completed using another ruby coil, the same microcatheter and handle.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 5.0 cm and 67.0 cm from the proximal end.The embolization coil was intact with the pusher assembly and undamaged.Conclusions: evaluation of the returned ruby coil revealed that the pet lock was intact on the proximal end of the pusher assembly.If the proximal end of the pusher assembly is not properly seated in the handle during an attempt to detach the embolization coil from its pusher assembly, the pet lock will not separate and retract the pull wire out of the distal detachment tip (ddt) resulting in the embolization coil detaching from its pusher assembly.During functional testing, the ruby coil was able to detach with a demonstration handle without issue.Further evaluation of the device revealed pusher assembly kinks.This damage was likely incidental to the complaint and could 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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10656454
• Report Number: 3005168196-2020-01678
• Device Sequence Number: 14340790
• Product Code: HCG
• UDI-Device Identifier: 00814548018263
• UDI-Public: 00814548018263
• 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): 09/14/2020
• 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: RBY4C0202-B
• Device Catalogue Number: RBY4C0202
• Device Lot Number: F94871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Date Report Sent to FDA: 01/01/2005