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

Catalog Number	RBY4C1240
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	02/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was disposed of by the hospital and is no longer available for return.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: 3005168196-2018-00487, 3005168196-2018-00489, 3005168196-2018-00490.The hospital discarded the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, the physician successfully deployed and detached a ruby coil using a lantern delivery microcatheter (lantern).The physician then attempted to deploy four other ruby coils, however was unable to due to the extreme angle of access into the aneurysm, despite making multiple adjustments to the placement of the lantern.Consequently, the physician felt resistance and the ruby coils unintentionally detached within the microcatheter.The physician removed the lantern to pull out each of the four detached ruby coils, and reinserted the same lantern.The procedure was then completed using the same lantern and additional ruby coils after the access sheath was adjusted.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: 7321485
• Report Number: 3005168196-2018-00488
• Device Sequence Number: 10789120
• Product Code: HCG
• UDI-Device Identifier: 00814548013237
• UDI-Public: 00814548013237
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 02/09/2018

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: 11/11/2025
• Device Catalogue Number: RBY4C1240
• Device Lot Number: F80525
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 03/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1