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

Model Number	RBY4C0835-A
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right gonadal vein using a lantern delivery microcatheter (lantern) and ruby coils.During the procedure, while advancing the ruby coil and non-penumbra microcatheter through a modified non-penumbra catheter in the target vessel, the ruby coil started taking shape inside the catheter; therefore, the physician decided to push and pull the ruby coil.While pushing and pulling the ruby coil, the physician experienced resistance, and the ruby coil unintentionally detached; therefore, the catheter containing the microcatheter and detached ruby coil were removed.It was reported that the removal of the entire system compromised further treatment due to a loss of access to the target vessel.The physician then opened a lantern.While removing the shaping mandrel from the distal tip of the lantern, the inner portion of the lantern was noticed to be hanging from the distal tip.The damage to the lantern was found prior to use, and therefore, it was not used in the procedure.The physician opened a second lantern, resumed the procedure, and was able to regain access to the target vessel.The procedure was completed using the second lantern, four ruby coils, and the same catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report:3005168196-2019-02039.1.Section h.Box 4.Device manufacture date 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: 9269838
• Report Number: 3005168196-2019-02039
• Device Sequence Number: 14021241
• Product Code: HCG
• UDI-Device Identifier: 00814548013206
• UDI-Public: 00814548013206
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2019
• 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 Expiration Date: 03/24/2026
• Device Model Number: RBY4C0835-A
• Device Catalogue Number: RBY4C0835
• Device Lot Number: F82525
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 11/02/2019
• Supplement Report FDA Received Date: 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Date Report Sent to FDA: 01/01/2005