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

Catalog Number	RBY2C0825
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the hypogastric-dependent pelvic varicea using ruby coils and a lantern delivery microcatheter (lantern).It should be noted that the patient''s anatomy was tortuous.During the procedure, the physician successfully implanted two coils into the target location.While advancing a ruby coil through the lantern, the physician visualized via fluoroscopy that the ruby coil had unintentionally detached while the ruby coil was partially inside the lantern and partially in the target location.Next, the physician flushed the lantern with saline solution using a 3ml syringe and successfully implanted the ruby coil.The procedure was completed using two additional ruby coils and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil pusher assembly confirmed that the embolization coil was detached.Evaluation revealed that the sr component was fractured, and the proximal constraint sphere was present inside the distal tip of the pusher assembly.If the ruby coil is manipulated against resistance during use, damage such as a sr component fracture may occur.This damage likely contributed to the ruby coil detachment during the procedure.Based on the reported complaint, the root cause of resistance 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 reported complaint and likely occurred during packaging of the device for return.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: 16892057
• Report Number: 3005168196-2023-00220
• Device Sequence Number: 6312441
• Product Code: HCG
• UDI-Device Identifier: 00814548012971
• UDI-Public: 814548012971
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/08/2023
• 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: RBY2C0825
• Device Lot Number: F109646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2023
• 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: 04/13/2023
• Initial Report FDA Received Date: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2021
• 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: 41 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005