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

Catalog Number	RBY2C0305
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	07/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using ruby coils and a non-penumbra microcatheter.During the procedure, while advancing a ruby coil through the microcatheter, the physician experienced resistance inside the microcatheter.Therefore, the physician decided to remove the ruby coil.However, while retracting, the physician still experienced resistance and the ruby coil had unintentionally detached inside the microcatheter.The physician then removed the microcatheter containing the detached ruby coil and the coil was flushed out.The microcatheter was then reinserted back into the vessel.Subsequently, it was reported that the same issue occurred with the next two ruby coils.Both detached ruby coils were contained inside of the microcatheter and the microcatheter was removed.Both ruby coils were then flushed out.The procedure was completed using a new ruby coil and the same 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.This report is associated with mfr report numbers: 1.3005168196-2023-00371 2.3005168196-2023-00372 h3 other text : placeholder.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil pusher assembly revealed that the pusher assembly was fractured.If the ruby coil is advanced against resistance during use, damage such as a kink and subsequent fracture on the pusher assembly may occur.This damage likely contributed to the ruby coil detachment during the procedure.The detached embolization coil was not returned for evaluation.Further evaluation of the device revealed kinks throughout the length of the pusher assembly.This damage was likely incidental to the complaint and occurred during packaging 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.This report is associated with mfr report numbers: 3005168196-2023-00371; 3005168196-2023-00372.

• 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: 17466777
• Report Number: 3005168196-2023-00373
• Device Sequence Number: 20628516
• Product Code: HCG
• UDI-Device Identifier: 00814548018546
• UDI-Public: 814548018546
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2023
• 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: RBY2C0305
• Device Lot Number: F00006398
• 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: 07/11/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2023
• 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: 74 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005