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

Catalog Number	RBY4C0406
Medical Device Problem Codes	Detachment Of Device Component (1104); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/26/2017
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 numbers: 3005168196-2017-01301, 3005168196-2017-01303.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, while attempting to advance a ruby coil through lantern, the physician experienced resistance and decided to retract the ruby coil; however, upon retraction, the ruby coil unintentionally detached in the lantern.Therefore, the physician removed the lantern containing the detached coil and flushed the coil out.The physician then re-inserted the lantern in the patient¿s body and attempted to advance a new ruby coil; however, resistance was encountered and upon retraction, the ruby coil unintentionally detached in the lantern.Therefore, the physician removed the lantern containing the detached coil.The procedure was completed using a non-penumbra coils and 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
• MDR Report Key: 6762320
• Report Number: 3005168196-2017-01302
• Device Sequence Number: 1412795
• Product Code: HCG
• UDI-Device Identifier: 00814548013169
• UDI-Public: 00814548013169
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/06/2017

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: 01/11/2025
• Device Catalogue Number: RBY4C0406
• Device Lot Number: F73783
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2017
• Initial Report FDA Received Date: 08/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1