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

Catalog Number	RBY2C0725
Medical Device Problem Codes	Kinked (1339); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/22/2017
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 number: 3005168196-2017-01811.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure using pod packing coils (podjs) and ruby coils.During the procedure, the physician felt resistance while attempting to advance a podj through its introducer sheath on the back table and found that the pusher wire had become kinked.The podj was therefore not used in the procedure.The physician then felt strong resistance while attempting to advance a ruby coil through a non-penumbra microcatheter and therefore, the ruby coil was removed.Upon removal, the physician found that the pusher wire of the ruby coil was kinked.The procedure was then completed using the same microcatheter and additional podjs and ruby coils.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: 6956564
• Report Number: 3005168196-2017-01812
• Device Sequence Number: 16421790
• Product Code: HCG
• UDI-Device Identifier: 00814548012957
• UDI-Public: 00814548012957
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Followup
• Report Date (Section B): 09/22/2017

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: 09/28/2024
• Device Catalogue Number: RBY2C0725
• Device Lot Number: F71855
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/22/2017
• Supplement Date Received by Manufacturer: 09/22/2017
• Initial Report FDA Received Date: 10/17/2017
• Supplement Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1