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

Catalog Number	RBY4C0204
Medical Device Problem Codes	Detachment Of Device Component (1104); Difficult or Delayed Activation (2577); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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: 3005168196-2018-00715.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left hepatic artery using ruby coils and a ruby coil detachment handle (handle).During the procedure, the physician successfully placed multiple coils using a non-penumbra microcatheter.The physician was then unable to detach a ruby coil using the handle.Therefore, the physician attempted to manually detach the ruby coil, however, the ruby coil still did not detach.The pusher assembly was, therefore, retracted to be removed, however, the physician felt resistance while retracting and the ruby coil unintentionally detached in the target location.The procedure was completed using an additional ruby coil, the same microcatheter, and the same handle.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
• MDR Report Key: 7401473
• Report Number: 3005168196-2018-00714
• Device Sequence Number: 1393058
• Product Code: HCG
• UDI-Device Identifier: 00814548013138
• UDI-Public: 00814548013138
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/08/2018

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: Physician
• Device Expiration Date: 11/08/2023
• Device Catalogue Number: RBY4C0204
• Device Lot Number: F66393
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 04/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 80