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

Catalog Number	RBYLP0310
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Difficult or Delayed Separation (4044); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using ruby coil lps, an lp system detachment handle (handle), a non-penumbra microcatheter, and a guidewire.During the procedure, a ruby coil lp would not advance at all past its initial position within its introducer sheath.It was reported that multiple unsuccessful attempts were made to advance the ruby coil lp.Therefore, the ruby coil lp was removed.Next, the physician successfully implanted one ruby coil lp in the target vessel using the handle.Then, the physician advanced another ruby coil lp to the target vessel using the microcatheter and attempted to detach it using the handle; however, the coil failed to detach.Subsequently, the physician manually detached the ruby coil lp by breaking the pusher assembly in several locations.It was reported that the ruby coil lp detached partially in the microcatheter and partially in the target vessel.Therefore, the physician advanced a guidewire (0.035¿) through the microcatheter to push the rest of the ruby coil lp out of the microcatheter and into the target vessel.The procedure was completed at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
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: 1.Section h.Box 6.Device code 2.Evaluation of the returned ruby coil lp could not confirm the reported complaint.Evaluation revealed that the pusher assembly was fractured in multiple locations and the embolization coil was detached from the pusher assembly.This damage likely occurred due to the reported manual detachment attempts, during the procedure.Based on the returned condition, the root cause of the reported complaint could not be determined.Penumbra products are visually 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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the reported detachment issue.H3 other text : placeholder.

• Brand Name: RUBY COIL LP
• 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: 14465960
• Report Number: 3005168196-2022-00223
• Device Sequence Number: 4904295
• Product Code: HCG
• UDI-Device Identifier: 00815948021785
• UDI-Public: 815948021785
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K192955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2022
• 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: RBYLP0310
• Device Lot Number: F109839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/25/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 05/21/2022
• Supplement Report FDA Received Date: 07/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2021
• 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 Age: 49 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005