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

Catalog Number	RBY4C1650
Medical Device Problem Codes	Break (1069); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat varices off the renal vein using ruby coils, ruby coil detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician placed and detached a ruby coil in the target location using the handle.Next, the physician advanced another ruby coil into the vessel and made multiple attempts to detach it using a handle and hemostats; however, the ruby coil failed to detach.Therefore, the physician decided to remove the ruby coil.Subsequently, while retracting the ruby coil, the physician noticed the distal end of the ruby coil pusher assembly broke inside the microcatheter.It was reported the ruby coil was already in the target location and was intertwined with the previously placed ruby coil.Therefore, when the physician was removing the microcatheter containing the broken pusher assembly with the ruby coil, the previously placed coil was also removed along with the ruby coil.The procedure was then completed using new ruby coils, same handle, and a new microcatheter.There was no report of an adverse effect to the patient.
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.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil confirmed that the pusher assembly was fractured.Evaluation revealed stretching on the fractured location.If the ruby coil is retracted against resistance, the pusher assembly may stretch and subsequently fracture.Further evaluation of the device revealed additional stretching and fractures on the pusher assembly, a kink near the distal tip of the pusher assembly, the embolization coil was detached and had offset coil winds.This damage was likely incidental to the complaint.Due to the returned damage, the device could not be functionally tested for reported detachment issue; therefore, the root cause of the reported detachment issue could not be determined.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.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: 16615962
• Report Number: 3005168196-2023-00134
• Device Sequence Number: 15020933
• Product Code: HCG
• UDI-Device Identifier: 00814548018904
• UDI-Public: 814548018904
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 04/10/2023
• 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: RBY4C1650
• Device Lot Number: F96446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2023
• 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: 03/01/2023
• Supplement Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2020
• 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: 78 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005