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

Catalog Number	RBY4C0620
Medical Device Problem Codes	Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.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.3005168196-2016-01621.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure treating a gastrointestinal (gi) bleed using ruby coils.During the procedure, upon advancing a ruby coil through a non-penumbra microcatheter, the physician was not satisfied with the way the ruby coil was packing; therefore, the physician decided to remove it.However while retracting the ruby coil, it unintentionally detached in the microcatheter as the physician was attempting to resheath it.Part of the ruby coil was hanging out of the hub of the microcatheter; therefore the physician removed the ruby coil by pulling it out.Next, the physician advanced a new ruby coil through the same microcatheter; however, the physician was not satisfied with the way this new ruby coil was packing; therefore the physician decided to remove it.However, upon attempting to resheath this ruby coil, it unintentionally detached with part of the coil outside of the hub of the microcatheter.The physician was able to pull the ruby coil out of the microcatheter and the procedure was completed using the same non-penumbra microcatheter and non-penumbra coils.The physician did not use a rotating hemostasis valve and did not maintain continuous flush.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: 6109473
• Report Number: 3005168196-2016-01620
• Device Sequence Number: 839996
• Product Code: HCG
• UDI-Device Identifier: 00814548013183
• UDI-Public: 00814548013183
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/18/2016

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: 02/09/2024
• Device Catalogue Number: RBY4C0620
• Device Lot Number: F67853
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2016
• Initial Report FDA Received Date: 11/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1