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

Catalog Number	RBY4C0415
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2022
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 in the inferior mesenteric artery (ima) using ruby coils, a ruby coil detachment handle (handle), a lantern delivery microcatheter (lantern), a non-penumbra catheter, and a non-penumbra sheath.It should be noted that the patient's anatomy was tortuous.During the procedure, the physician successfully implanted one ruby coil into the target location.While introducing the next ruby coil, it unintentionally detached inside the lantern when the distal end of the coil was approximately in the middle to distal end of the lantern.Therefore, the lantern containing the detached ruby coil was removed and the coil was flushed out on the back table.The procedure was completed using another ruby coil of the same size, the same handle, the same lantern, the same catheter, and the same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra distributor indicated that the device was accidentally lost and is no longer available for return.Therefore, without the return of the device, the root cause of the problem cannot be determined.Based on this information, corrections were made to: section d.Box 10.Device available for evaluation? (do not send to fda).Section h.Box 3.Reason for non-evaluation.Section h.Box 3.''other'' reason for non-evaluation.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• 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: 15138259
• Report Number: 3005168196-2022-00363
• Device Sequence Number: 7323074
• Product Code: HCG
• UDI-Device Identifier: 00814548018348
• UDI-Public: 814548018348
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/06/2022
• 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: F108600
• 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: 07/07/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 08/01/2022
• Supplement Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2021
• 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: Male
• Date Report Sent to FDA: 01/01/2005