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

Catalog Number	RBY2C0825-A
Medical Device Problem Codes	Bent (1059); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2016
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 numbers: report 3005168196-2016-01401.Report 3005168196-2016-01403.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, the physician experienced resistance while advancing a ruby coil through a lantern delivery microcatheter (lantern), and the ruby coil pusher assembly became bent; therefore it was removed.The physician then advanced a new ruby coil to the target vessel using the same lantern; however, the physician wanted to reposition the ruby coil and therefore retracted the ruby coil quickly with resistance, causing it to shred apart.The ruby coil unintentionally detached in the patient body, therefore, the physician used a snare device to retrieve all the parts of the detached ruby coil from the patient.The procedure was completed using a new ruby coil and additional non-penumbra coils, and the same lantern.The physician flushed between each coil and did not use a rotating hemostasis valve.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: 5990643
• Report Number: 3005168196-2016-01400
• Device Sequence Number: 408609
• Product Code: HCG
• UDI-Device Identifier: 00814548012971
• UDI-Public: 00814548012971
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/01/2016

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: 11/16/2023
• Device Catalogue Number: RBY2C0825-A
• Device Lot Number: F66560
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2016
• Initial Report FDA Received Date: 09/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1