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

Catalog Number	RBY4C0835
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using ruby coils, a ruby coil detachment handle (handle), and a non-penumbra microcatheter.It should be noted that the patient's anatomy was tortuous.During the procedure, the physician advanced the first ruby coil into the target location and attempted to detach the coil with the handle; however, the ruby coil did not detach after three attempts.Therefore, the handle was removed and was no longer used in the procedure.While retracting the ruby coil, it unintentionally detached.It was reported that approximately twenty centimeters of the ruby coil remained inside the target vessel when the coil detached.The physician decided to flush the ruby coil out of the microcatheter and inadvertently occluded a non-target vessel.The physician used another ruby coil to push the previous ruby coil into the target vessel, and a stent graft was placed over the ruby coils.The procedure was completed using one ruby coil, four pod packing coils (pod pcs), a new handle, 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detached.Evaluation revealed that the pet lock separated on the proximal end of the pusher assembly and the pull wire was retracted out.This typically occurs during a detachment attempt.Based on the returned condition, the root cause of this complaint could not be determined.Further evaluation revealed that the pusher assembly was fractured.This damage was incidental to the reported compliant.However, this damage could have also contributed to the reported detachment issue.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: 15899614
• Report Number: 3005168196-2022-00560
• Device Sequence Number: 5103172
• 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): 12/08/2022
• 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
• Date Returned to Manufacturer: 11/18/2022
• 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: 11/06/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 12/08/2022
• 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: Unknown
• Date Report Sent to FDA: 01/01/2005