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

Catalog Number	RBY4C0406
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2023
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 ruby coil detachment handle (handle), and a non-penumbra microcatheter.It was noted that the patient''s anatomy was tortuous.During the procedure, the physician advanced a ruby coil into the target location using the microcatheter and attempted to detach the ruby coil using the handle.However, the ruby coil failed to detach.The physician then made five to six attempts to detach the ruby coil using the handle and by manually detaching it but were unsuccessful.Therefore, the physician decided to remove the ruby coil.Upon retraction, the ruby coil unintentionally detached.The physician then flushed the detached ruby coil into the target location.The physician then advanced another ruby coil into the target location using the microcatheter and attempted to detach the ruby coil using the handle; however, the ruby coil failed to detach.The physician then attempted to manually detach the ruby coil but was unsuccessful.Therefore, the ruby coil was removed intact.The procedure was completed using two other coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The ruby coil was implanted in the patient; however, the pusher assembly has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.H3 other text : placeholder.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil could not confirm the coil detachment issue due to the returned condition.Evaluation revealed that the pet lock was separated and was wrinkled on its proximal end, the pusher assembly was fractured, the pull wire was retracted from the distal tip of the pusher assembly and the embolization coil was detached from the pusher assembly.This damage likely occurred during manual detachment as mentioned in the complaint.Based on the returned condition, the ruby coil was unable to be functionally tested.Therefore, the root cause of the reported complaint could not be determined.The detached embolization coil was not returned for evaluation.Further evaluation revealed kinks along the length of the pusher assembly.This damage was incidental to the complaint.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.

• 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: 18373518
• Report Number: 3005168196-2023-00567
• Device Sequence Number: 15353730
• Product Code: HCG
• UDI-Device Identifier: 00814548018331
• UDI-Public: 814548018331
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2024
• 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: RBY4C0406
• Device Lot Number: F00006088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• 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: 11/23/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2023
• 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: 86 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005