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

Catalog Number	RBY4C0835
Medical Device Problem Codes	Failure to Fold (1255); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils, a lantern delivery microcatheter (lantern), a non-penumbra guide catheter, and an angiographic catheter.It should be noted that the patient's anatomy was tortuous and calcified.During the procedure, the physician advanced the first ruby coil into the target location and reported that it was not taking the desired shape.The physician advanced and retracted the pusher wire four to five times; however, the ruby coil did not track with the pusher wire.The lantern containing the ruby coil was removed and the physician confirmed that the coil had unintentionally detached inside the lantern.Therefore, the ruby coil was flushed out of the lantern on the back table.While advancing the next ruby coil into the target vessel, the coil did not take the desired shape.The physician attempted to retract the ruby coil and noticed that the coil did not track with the pusher wire.It was reported that the same issue occurred and the ruby coil was unintentionally detached inside the lantern.Therefore, the lantern containing the ruby coil was removed and the coil was flushed out on the back table.The procedure was completed using a pod coil, thirteen coils including ruby coils and pod packing coils (pod pcs), the same lantern, the same guide catheter, and the same angiographic catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil confirmed the reported complaint.Evaluation revealed that the embolization coil was detached from the pusher assembly.Further evaluation revealed that the pusher assembly was kinked and fractured.If the device is manipulated at extreme angles during use, damage such as a kink and subsequent fracture may occur.Subsequently, if the two fractured pieces are separated, the pull wire will retract out of the ddt and the embolization coil will detach.Further evaluation also revealed pusher assembly kinks and offset coil winds on the embolization coil.This damage was incidental to the reported complaint and may have occurred after removal of the device from the procedure.Penumbra coils 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.This report is associated with mfr report number: 3005168196-2022-00435.

• 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: 15440711
• Report Number: 3005168196-2022-00434
• Device Sequence Number: 5845079
• Product Code: HCG
• UDI-Device Identifier: 00814548018386
• UDI-Public: 814548018386
• 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
• Report Date (Section B): 09/16/2022
• 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: RBY4C0835
• Device Lot Number: F110172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2022
• 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: 08/23/2022
• Initial Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2021
• 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: Female
• Date Report Sent to FDA: 01/01/2005