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

Catalog Number	RBY4C0415
Medical Device Problem Codes	Migration (4003); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the hepatic artery using ruby coils and a non-penumbra microcatheter and a guidewire.During the procedure, the physician successfully implanted a ruby coil in the target vessel using the microcatheter.Next, a new ruby coil would not advance out of its introducer sheath.Therefore, the ruby coil was removed.The physician then advanced a third ruby coil through the microcatheter; however, the ruby coil unintentionally detached into another vessel.Therefore, the detached ruby coil was removed using a snare device.The procedure ended at this point.There was no report of an adverse effect to the patient.
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 portal vein using ruby coils, a non-penumbra microcatheter, and a guidewire.During the procedure, the physician successfully implanted a ruby coil in the target vessel using the microcatheter.A new ruby coil would not advance out of its introducer sheath.Therefore, the ruby coil was removed.The physician then advanced a third ruby coil through the microcatheter.Subsequently, the ruby coil unintentionally detached and migrated to the left portal vein.The detached ruby coil was removed using a snare device.The procedure ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were being updated based on additional information provided by a penumbra sales representative on 08/23/2022: 1.Section b.Box 5.Describe event or problem.2.Section h.Box 6.Device code 2 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: 15021470
• Report Number: 3005168196-2022-00335
• Device Sequence Number: 16754268
• Product Code: HCG
• UDI-Device Identifier: 00814548013176
• UDI-Public: 814548013176
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2022
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: RBY4C0415
• Device Lot Number: F93228
• Was Device Available for Evaluation?: No
• 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: 06/16/2022
• Supplement Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2019
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/01/2005