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

Catalog Number	RBY2C2860
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned ruby coil confirmed the embolization coil was detached, and only the pusher assembly was returned for evaluation.Evaluation revealed that the pet lock was intact on the proximal end of the pusher assembly, the pull wire was in its initial position inside the pusher assembly distal tip, and the embolization coil¿s proximal constraint sphere was present inside the pusher assembly distal tip.This indicates that the embolization coil was likely detached due to a fractured sr component.This type of damage typically occurs if the device is retracted against resistance during use.Based on the reported complaint, the root cause of resistance could not be determined.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the superior mesenteric vein (smv) using a ruby coil and a lantern delivery microcatheter (lantern).During the procedure, while advancing the ruby coil in the target vessel, the physician retracted the coil slightly in an attempt to re-position it and realized under fluoroscopy that the ruby coil was unintentionally detached inside the distal end of the lantern.The physician then used the ruby coil pusher wire to push the detached coil out of the lantern into the target location.The procedure was completed using additional ruby coils and the same lantern.There was no report of an adverse effect to the patient.

• 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: 20457285
• Report Number: 3005168196-2024-00347
• Device Sequence Number: 8701669
• Product Code: HCG
• UDI-Device Identifier: 00814548019314
• UDI-Public: 00814548019314
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 10/15/2024
• 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
• Device Catalogue Number: RBY2C2860
• Device Lot Number: F00010262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2024
• 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: 09/19/2024
• Initial Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2024
• 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: Unknown
• Date Report Sent to FDA: 01/01/2005