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

Model Number	RBY4C0630-B
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned ruby coil confirmed that the embolization coil was detached inside the lantern.Evaluation revealed that the pull wire was within the pusher assembly ddt.If the ruby coil is forcefully retracted against resistance, the pusher assembly may elongate beyond the reach of the pull wire and allow the embolization coil to detach.The ovalization on the lantern likely contributed to resistance during retraction of the ruby coil during the procedure.The pusher assembly was able to be removed from the lantern without an issue.Further evaluation of the device revealed that the pet lock was damaged but intact on the proximal end of the pusher assembly and the pusher assembly was kinked.If the device is advanced against resistance damage such as this may occur.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in a gluteal vessel off of the hypogastric artery using a lantern delivery microcatheter (lantern), ruby coils, a diagnostic catheter, and a non-penumbra sheath.It should be noted that the patient's anatomy was tortuous.During the procedure, resistance was encountered when the lantern was advanced approximately two-thirds of the way through the diagnostic catheter.When the lantern was approximately three-fourths of the way through the diagnostic catheter, it would not advance further.Upon removal, the distal end of the lantern was ovalized.The physician opened a new lantern and successfully advanced it through the same diagnostic catheter during testing on the back table.However, while attempting to introduce the lantern to the patient, resistance was encountered during advancement through the distal end of the diagnostic catheter.Upon removal, the distal end of the lantern was ovalized.Therefore, the diagnostic catheter was also removed from use.Next, the physician added a long sheath and used a new diagnostic catheter with a new lantern.Resistance was encountered while advancing a ruby coil through the distal end of the lantern and the coil would not advance further.While retracting the ruby coil, resistance was also encountered and, subsequently, the coil unintentionally detached inside the lantern.Therefore, the lantern containing the ruby coil and the diagnostic catheter were removed together from the patient.Upon removal, the physician noted that the distal end of the lantern was ovalized.At this point, the physician decided not to use a microcatheter, and used the same diagnostic catheter to continue the procedure.During advancement of the second ruby coil through the diagnostic catheter, the physician inadvertently kinked the ruby coil pusher wire.Therefore, the ruby coil was removed.The procedure was completed using thirteen additional ruby coils, the same diagnostic catheter, the same long sheath, and the same sheath.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: 13905022
• Report Number: 3005168196-2022-00137
• Device Sequence Number: 4277262
• Product Code: HCG
• UDI-Device Identifier: 00814548018362
• UDI-Public: 00814548018362
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2022
• 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 Model Number: RBY4C0630-B
• Device Catalogue Number: RBY4C0630
• Device Lot Number: F97150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2022
• 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: 03/02/2022
• Initial Report FDA Received Date: 03/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2020
• 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: 69 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005