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

Catalog Number	RBY4C0315
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	07/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the pulmonary arteriovenous malformations (avm) using ruby coils and a non-penumbra microcatheter.It was reported that the microcatheter was flushed.During the procedure, while advancing a ruby coil through the microcatheter, the physician experienced resistance inside of the microcatheter and stopped advancing the ruby coil.The physician performed a fluoroscopy and noticed that the ruby coil was not visible on the screen.The ruby coil pusher assembly was retracted into the microcatheter and the physician attempted to re-advance the coil; however, the ruby coil was stuck and would not advance.The ruby coil was then removed and retracted back into its introducer sheath and the microcatheter was double flushed.The physician made another attempt to advance the same ruby coil through the microcatheter, but the same issue had occurred.The ruby coil pusher assembly was removed and the physician noticed that the ruby coil was not attached to the pusher assembly.The microcatheter was removed and flushed again.When the physician placed the microcatheter under fluoroscopy, the ruby coil was found to be detached and stuck inside the microcatheter.The microcatheter was not used for the remainder of the procedure.The procedure was completed using new ruby coils and new microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil confirmed that the embolization coil was detached from the pusher assembly.Evaluation revealed that the pet lock was intact, the pull wire was in its original position on the distal tip of the pusher assembly.If the ruby coil is retracted against resistance, the pusher assembly may elongate beyond the reach of the pull wire and result in the embolization coil detaching from the pusher assembly.The ovalization along the non-penumbra catheter shaft likely contributed to resistance.Further evaluation revealed kinks in the pusher assembly.This damage was incidental to the reported complaint and may have occurred during packaging of the device for return to penumbra.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.

• 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: 17470266
• Report Number: 3005168196-2023-00379
• Device Sequence Number: 7357561
• Product Code: HCG
• UDI-Device Identifier: 00814548018324
• UDI-Public: 814548018324
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 08/07/2023
• 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: RBY4C0315
• Device Lot Number: F112547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2023
• 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: 07/12/2023
• Initial Report FDA Received Date: 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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: 32 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005