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

Catalog Number	RBY2C0630
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.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 the right hepatic artery using a ruby coil, a lantern delivery microcatheter (lantern), and a guide catheter.During the procedure, the physician placed five penumbra coils in the target location using the lantern.It was reported that the lantern was not flushed.Next, while advancing a ruby coil into the target vessel using the lantern, the physician experienced resistance and the ruby coil had unintentionally detached.Therefore, the physician removed the lantern and the pusher assembly of the ruby coil as a unit.It was reported that the physician noticed under fluoroscopy that a portion of the detached ruby coil remained in the guide catheter.Subsequently, the physician noticed the lantern was fractured proximal to the hub.The physician then used a snare device to push the detached portion of the ruby coil into the aneurysm.No additional information regarding the completion of the procedure was provided.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was updated for clarification: 1.Section b.Box 5.Describe event or problem.Evaluation of the returned ruby coil could not confirm the reported embolization coil detachment.Evaluation revealed that the embolization coil was intact with the pusher assembly and undamaged.Further evaluation of the device revealed kinks on the pusher assembly.This damage typically occurs if the device is manipulated against resistance during use.The root cause of the pusher assembly kinks could not be determined and were incidental to the reported unintentional detachment.Penumbra devices 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.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right hepatic artery using a ruby coil, a lantern delivery microcatheter (lantern), and a guide catheter.During the procedure, the physician placed five penumbra coils in the target location using the lantern.It was reported that the lantern was not flushed.Next, while advancing a ruby coil into the target vessel using the lantern, the physician experienced resistance and the ruby coil had unintentionally detached.Therefore, the physician removed the lantern and the pusher assembly of the ruby coil as a unit.It was reported that the physician noticed under fluoroscopy that the detached ruby coil remained in the guide catheter.Subsequently, the physician noticed the lantern was fractured several inches from the hub.The physician then used a snare device to push the detached ruby coil into the aneurysm.No additional information regarding the completion of the procedure was provided.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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 14322749
• Report Number: 3005168196-2022-00206
• Device Sequence Number: 11908867
• Product Code: HCG
• UDI-Device Identifier: 00814548018812
• UDI-Public: 814548018812
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2022
• 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 Catalogue Number: RBY2C0630
• Device Lot Number: F94363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• 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: 04/12/2022
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005