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

Catalog Number	RBY2C2457
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using a ruby coil and a non-penumbra microcatheter.It should be noted that the patient¿s anatomy was moderately tortuous.During the procedure while advancing the ruby coil through the microcatheter, the physician experienced resistance.The physician continued to advance the ruby coil and while advancing the ruby coil through the mid-shaft of the microcatheter, the ruby coil stopped advancing.The physician kinked the pusher assembly of the ruby coil and the coil unintentionally detached within the microcatheter.Therefore, the microcatheter containing the detached ruby coil was removed.It was reported that the ruby coil was flushed out of the microcatheter on the back table.The procedure was completed using seventeen coils (ruby coils and pod packing coils), and the same 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.If the ruby coil is advanced against resistance, damage such as a kink may occur.Subsequent manipulation of a kinked pusher assembly may lead to a fracture, resulting in a detached embolization coil.Based on the reported event, the root cause of resistance could not be determined.The pusher assembly was not returned for evaluation.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.

• 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: 20081524
• Report Number: 3005168196-2024-00297
• Device Sequence Number: 7664043
• Product Code: HCG
• UDI-Device Identifier: 00814548019291
• UDI-Public: 00814548019291
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2024
• 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: RBY2C2457
• Device Lot Number: F00009712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2024
• 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: 07/31/2024
• Initial Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2023
• 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: 77 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005