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

Model Number	RBY4C0620-A
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2020
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 mid splenic artery using a ruby coil, pod coil, pod packing coil (pod pc), non-penumbra 5fr sheath, guide catheter (c2), and non-penumbra microcatheter.During the procedure, the physician accessed the right groin using the 5fr sheath and a guide catheter was advanced through the sheath.The physician then advanced the microcatheter through the guide catheter and placed a pod coil and pod pc in the target vessel using the microcatheter.Next, while attempting to place a ruby coil in the vessel, the physician advanced approximately 20 percent of the ruby coil out the distal tip of the microcatheter; however, the ruby coil unintentionally detached with 80 percent of the ruby coil still inside the microcatheter.Therefore, the physician removed the microcatheter and guide catheter containing the detached ruby coil and the coil was flushed out on the back table.The procedure was completed using other coils with the same microcatheter, guide catheter, and sheath.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11023195
• Report Number: 3005168196-2020-02282
• Device Sequence Number: 17099491
• Product Code: HCG
• UDI-Device Identifier: 00814548013183
• UDI-Public: 00814548013183
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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
• Report Date (Section B): 11/20/2020
• 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 Expiration Date: 03/23/2024
• Device Model Number: RBY4C0620-A
• Device Catalogue Number: RBY4C0620
• Device Lot Number: F68655
• Was Device Available for Evaluation?: No
• 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: 11/20/2020
• Initial Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005