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

Catalog Number	RBY2C0520
Medical Device Problem Codes	Detachment Of Device Component (1104); Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2017
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: 3005168196-2017-02321, 3005168196-2017-02322, 3005168196-2017-02323, 3005168196-2017-02324.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using a lantern delivery microcatheter (lantern) and ruby coils.During the procedure, while advancing a ruby coil through the lantern, the physician experienced resistance and the ruby coil was unable to advance any further.Upon attempting to retract the ruby coil, the physician experienced resistance again and the ruby coil unintentionally detached within the lantern.Therefore, the physician removed the lantern with the detached ruby coil from the patient and flushed out the ruby coil, before reinserting the lantern.However, this same incident occurred with three additional ruby coils.When the physician removed the lantern with the fourth detached ruby coil, a kink was found on the lantern.The procedure was therefore completed using a px slim delivery microcatheter (px slim) and a new ruby coil.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: 7148199
• Report Number: 3005168196-2017-02320
• Device Sequence Number: 1109709
• Product Code: HCG
• UDI-Device Identifier: 00814548012902
• UDI-Public: 00814548012902
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/01/2017

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: 08/08/2025
• Device Catalogue Number: RBY2C0520
• Device Lot Number: F78628
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 12/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1