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

Catalog Number	RBY4C0835
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	12/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left internal iliac artery (iia) using ruby coils, a lantern delivery microcatheter (lantern), a non-penumbra catheter, and a non-penumbra guide catheter.It should be noted that the patient''s anatomy was tortuous.During the procedure, the physician encountered resistance while advancing a ruby coil through the middle of the lantern.The physician continued to advance the ruby coil against resistance and kinked the pusher wire.While attempting to retract the ruby coil, the physician noticed that the coil did not follow the pusher wire and reported that it was unintentionally detached inside the lantern.Therefore, a syringe was connected to the lantern containing the detached ruby coil.The devices were removed together while negative pressure was applied via the syringe.The lantern was then flushed and re-inserted into the target site.The procedure was completed using the same lantern, another ruby coil of the same size, and four additional coils.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.Evaluation revealed that the proximal constraint sphere was not present at the proximal end of the embolization coil, the embolization coil was fractured and unraveled at its proximal end and had offset coil winds throughout its length.Based on the reported event, this damage was likely incidental to the complaint and likely occurred during removal of the coil from the microcatheter.The pusher assembly was not returned for evaluation; therefore, the reported pusher assembly kink during advancement was unable to be confirmed.Due to the returned condition, the root cause of the coil detachment 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.

• 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: 16075122
• Report Number: 3005168196-2022-00598
• Device Sequence Number: 6295043
• Product Code: HCG
• UDI-Device Identifier: 00814548018386
• UDI-Public: 814548018386
• 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,Followup
• Report Date (Section B): 01/10/2023
• 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: RBY4C0835
• Device Lot Number: F00001983
• 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: 12/06/2022
• Supplement Date Received by Manufacturer: 12/30/2022
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2022
• 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 Sex: Male
• Date Report Sent to FDA: 01/01/2005