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

Catalog Number	RBY2C1260
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	11/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a carotid cavernous fistula (ccf) using a ruby coil and a px slim delivery microcatheter (px slim).It was reported that the patient¿s anatomy was tortuous.During the procedure, the physician placed the px slim into the patient.Next, while advancing the ruby coil through the px slim, the physician experienced resistance and decided to retract the ruby coil.Upon retraction of the ruby coil pusher assembly, the physician noticed that the ruby coil had unintentionally detached within the px slim.Therefore, the px slim containing the detached ruby coil was removed.The procedure was completed using a new ruby coil and a new px slim.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.Evaluation revealed that the distal tip of the pusher assembly was fractured.If the ruby coil is retracted against resistance, damage such as this may occur.Further evaluation revealed a kink in the pusher assembly and offset coil winds on the embolization coil.The offset coil winds may have contributed to resistance during the procedure.The kink on the pusher assembly was incidental to the reported complaint and likely occurred during packaging of the device for return.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: 15943596
• Report Number: 3005168196-2022-00570
• Device Sequence Number: 17692357
• Product Code: HCG
• UDI-Device Identifier: 00814548013022
• UDI-Public: 814548013022
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K120330
• 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,Followup
• Report Date (Section B): 09/21/2023
• 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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: RBY2C1260
• Device Lot Number: F94889
• 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: 11/13/2022
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2019
• 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: 71 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005