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

Model Number	RBY2C1260-B
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a hepatic artery pseudoaneurysm using a lantern delivery microcatheter (lantern), ruby coils, a ruby coil detachment handle (handle) and guidewire.It was noted that the patient's anatomy was tortuous.During the procedure, the physician placed a ruby coil in the target location using the lantern.The physician then advanced another ruby coil in the target location using the lantern and used the handle to detach it.However, while slowly removing the pusher assembly of the ruby coil under fluoroscopy, the physician noticed that the ruby coil had not detached and subsequently, the ruby coil was pulled out of the pseudoaneurysm.While the physician attempted to push the ruby coil back into position, the ruby coil unintentionally detached with the distal end of the ruby coil in the hepatic artery.Therefore, the physician removed the detached ruby coil using a snare device.The physician decided to end the procedure at this point since the ruby coil that was previously placed had closed the pseudoaneurysm.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil confirmed that the embolization coil was detached from its pusher assembly.Evaluation revealed that the pet lock was intact on the proximal end of the pusher assembly.This indicates that the reported detachment was not properly attempted during the procedure.If the proximal end of the pusher assembly is not properly inserted into the handle prior to the detachment attempt, the embolization will not detach from its pusher assembly.Further evaluation revealed that the sr wire component was fractured.This type of damage typically occurs if the device is retracted against resistance.This damage likely contributed to the embolization coil detaching from its pusher assembly.Further evaluation revealed multiple kinks throughout the length of the pusher assembly.This damage was incidental to the reported complaint and the root cause could not be determined.Penumbra products 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.

• 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: 13697298
• Report Number: 3005168196-2022-00109
• Device Sequence Number: 12353135
• Product Code: HCG
• UDI-Device Identifier: 00814548019093
• UDI-Public: 00814548019093
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2022
• 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: RBY2C1260-B
• Device Catalogue Number: RBY2C1260
• Device Lot Number: F102193
• 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: 02/09/2022
• Supplement Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2020
• 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: 65 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005