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

Model Number	RBY4C0630-B
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
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.This report is associated with mfr report number: 3005168196-2020-02347.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the three branch vessels of the internal iliac artery (iia) using pod coils, 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, two pod coils and one ruby coil were implanted in a branch vessel using the handle.While attempting to advance a pod coil into the second branch vessel, the coil detached inside the microcatheter and partially in the vessel.However, the physician was able to push it into the target site.Next, the physician encountered resistance while advancing a ruby coil and subsequently, the ruby coil detached while advancing through the proximal shaft of the microcatheter.Therefore, the microcatheter and ruby coil were removed from the patient together and the ruby coil was removed from the microcatheter.The procedure was completed using four additional ruby coils, the same handle, and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was damaged and slipped off the hypotube on the proximal end of the pusher assembly.The pull wire was retracted out of the pusher assembly distal detachment tip (ddt).Conclusions: evaluation of the returned ruby coil confirmed a detached embolization coil.Further evaluation revealed that the pet lock on the proximal end of the pusher assembly was damaged and slipped off the hypotube.The root cause of this damage could not be determined; however, if this occurs, the pull wire may retract out of the pusher assembly ddt and the embolization coil will detach.The embolization coil was not returned for evaluation.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.H3 other text : placeholder.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11067855
• Report Number: 3005168196-2020-02348
• Device Sequence Number: 4396682
• Product Code: HCG
• UDI-Device Identifier: 00814548018362
• UDI-Public: 00814548018362
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2020
• 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: RBY4C0630-B
• Device Catalogue Number: RBY4C0630
• Device Lot Number: F89462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005