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

Model Number	RBY2C1857-A
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	10/10/2021
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 treating a duodenal fistula (df) using ruby coils and a px slim delivery microcatheter (px slim).It should be noted that the patient's anatomy was tortuous.During the procedure, resistance was encountered while retracting a ruby coil and, subsequently, the ruby coil unintentionally detached.Therefore, the ruby coil was removed.The procedure was completed using a pod packing coil (pod pc) and the same px slim.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure treating a dural arteriovenous fistula (davf) using ruby coils and a px slim delivery microcatheter (px slim).It should be noted that the patient's anatomy was tortuous.During the procedure, the ruby coil was advanced into the target location for framing when the physician decided to re-position the coil.While retracting the ruby coil, resistance was encountered and, subsequently, the ruby coil unintentionally detached when it was partially in the vessel and the px slim.Therefore, the detached ruby coil was removed using a snare kit.The procedure was completed using a pod packing coil (pod pc) 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 the pusher assembly.Evaluation revealed that the pusher assembly was fractured at its proximal end, and the pull wire was retracted from the fractured location.If the pusher assembly is handled at extreme angles during use, damage such as a kink and subsequent fracture may occur.If the pusher assembly is fractured, the embolization coil will likely become detached from the pusher assembly.Further evaluation of the device revealed that the distal end of the embolization coil was advanced distal to the introducer sheath and was unraveled.This damage was likely incidental to the complaint and may have occurred during removal of the coil using a snare kit.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up report: 1.Section b.Box 5.Describe event or problem 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: 12800681
• Report Number: 3005168196-2021-02545
• Device Sequence Number: 20028210
• Product Code: HCG
• UDI-Device Identifier: 00814548013060
• UDI-Public: 00814548013060
• 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): 11/22/2021
• 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 Model Number: RBY2C1857-A
• Device Catalogue Number: RBY2C1857
• Device Lot Number: F95079
• 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: 11/11/2021
• Supplement Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2019
• 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: 77 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005