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

Catalog Number	RBY4C0305-A
Medical Device Problem Codes	Kinked (1339); Physical Resistance (2578); Device Handling Problem (3265)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/12/2016
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: 3005168196-2016-01298.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, while advancing two ruby coils through a lantern delivery microcatheter (lantern), two assisting residents encountered resistance and decided to apply extra force to push the coils forward rather than retracting and repositioning the lantern.Consequently, both ruby coil pusher assemblies were inadvertently kinked by the two assisting residents.Therefore, both ruby coils were removed and the procedure was completed using additional ruby coils and the same lantern.It should be noted that the lantern was flushed before each coil insertion and that a rotating hemostasis valve (rhv) was used throughout the procedure.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: 5940975
• Report Number: 3005168196-2016-01297
• Device Sequence Number: 10880682
• Product Code: HCG
• UDI-Device Identifier: 00814548013145
• UDI-Public: 00814548013145
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2016

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: 06/30/2023
• Device Catalogue Number: RBY4C0305-A
• Device Lot Number: F64297
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2016
• Initial Report FDA Received Date: 09/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1