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

Model Number	RBY2C0410-B
Medical Device Problem Codes	Material Deformation (2976); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left arteriovenous fistula (avf) using ruby coils and a non-penumbra microcatheter.During the procedure, while advancing a ruby coil into the target vessel using the microcatheter, the hospital technician bent the pusher assembly of the ruby coil and, consequently, the ruby coil unintentionally detached.Therefore, the physician used a syringe to aspirate and remove the detached ruby coil.The same issue then occurred with the next ruby coil.Therefore, the physician removed the microcatheter containing the detached ruby coil and the coil was flushed out.The procedure was completed using new ruby coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the second returned ruby coil confirmed that the embolization coil was detached, and the pusher assembly was kinked.Evaluation revealed a pusher assembly fracture near the kinked location.If the device is inadvertently mishandled at an extreme angle during advancement, damage such as a kink and a fracture on the pusher assembly may occur.The fractured pusher assembly likely contributed to the embolization coil detachment during the procedure.The detached embolization coil was not returned for evaluation.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.This report is associated with mfr report number: 3005168196-2022-00152.

• 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: 14016071
• Report Number: 3005168196-2022-00153
• Device Sequence Number: 12001157
• Product Code: HCG
• UDI-Device Identifier: 00814548018577
• UDI-Public: 00814548018577
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/04/2022
• 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 Expiration Date: 09/26/2026
• Device Model Number: RBY2C0410-B
• Device Catalogue Number: RBY2C0410
• Device Lot Number: F86122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2022
• 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: 03/10/2022
• Initial Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2017
• 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