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

Catalog Number	RBY4C0204
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned ruby coil pusher assembly confirmed that the pusher assembly was fractured, and the embolization coil was detached.If the ruby coil is manipulated at an angle during preparation, the pusher can become kinked.This damage likely contributed to the reported resistance experienced during advancement of the ruby coil.Subsequent use of a previously damaged pusher and additional manipulation against resistance likely lead to the pusher assembly fracturing.If the pusher assembly fractures, the embolization coil will likely detach.The detached embolization coil was not returned for evaluation.Further evaluation of the device revealed additional kinks along the length of the pusher assembly.Based on the returned packaging condition, this damage was incidental to the complaint and likely occurred during packaging for the device return.Penumbra coils are 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 a branch of the gastroduodenal artery (gda) using ruby coils and a non-penumbra microcatheter.During the procedure, the nurse kinked the ruby coil pusher wire and then attempted to straighten it.The physician then experienced resistance while advancing the ruby coil into the microcatheter and subsequently noticed that the pusher wire was fractured.While removing the distal end of the ruby coil pusher wire, the ruby coil unintentionally detached in the proximal end of the microcatheter.The physician then manually aspirated the ruby coil out of the microcatheter using a syringe.The procedure was completed using additional ruby coils and the same microcatheter.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: 18765254
• Report Number: 3005168196-2024-00060
• Device Sequence Number: 7627583
• Product Code: HCG
• UDI-Device Identifier: 00814548018270
• UDI-Public: 814548018270
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/22/2024
• 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: RBY4C0204
• Device Lot Number: F00008266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2024
• 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: 01/25/2024
• Initial Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2023
• 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: 37 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005