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

Model Number	RBY2C1660-A
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2021-02539.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the carotid cavernous fistula (ccf) using ruby coils and a px slim delivery microcatheter (px slim).During the procedure, the physician was unable to advance a ruby coil out from the introducer sheath.Therefore, the ruby coil was removed.The physician then placed two ruby coils in the vessel using the px slim.Subsequently, while advancing another ruby coil into the target location, the ruby coil had unintentionally detached.Therefore, the physician used a snare device to remove the detached ruby coil.The procedure was completed using new ruby coils and the same px slim.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 from its pusher assembly.The pusher assembly of the ruby coil was not returned for evaluation.Therefore, the root cause of the ruby coil unintentionally detached during the procedure could not be determined.Further evaluation of the device revealed offset coil winds on the embolization coil.This damage was likely incidental to the complaint and likely occurred during removal from the patient body.Evaluation of the returned ruby coil revealed that the embolization coil was detached from its pusher assembly and loaded backward into the introducer sheath and had offset coils.This damage was likely incidental to the complaint.The pusher assembly was not returned for evaluation.Due to the returned condition, the root cause of the reported ruby coil not advancing out of the introducer sheath, during the procedure could not be determined.During decontamination, the detached embolization coil was able to flush out of the introducer sheath with solution without an issue.Penumbra coils are 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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the reported complaint due to the return condition.This report is associated with mfr report number: 1.3005168196-2021-02539 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: 12783771
• Report Number: 3005168196-2021-02538
• Device Sequence Number: 14519367
• Product Code: HCG
• UDI-Device Identifier: 00814548013053
• UDI-Public: 00814548013053
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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): 01/11/2022
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: RBY2C1660-A
• Device Catalogue Number: RBY2C1660
• Device Lot Number: F90598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• 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: 10/15/2021
• Supplement Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005