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

Catalog Number	RBY2C2860
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2017
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat an arteriovenous fistula (avf) in the right anterior tibial artery using ruby coils.During the procedure, the physician experienced resistance and was unable to advance a ruby coil out of its introducer sheath and into a lantern delivery microcatheter (lantern); therefore, it was removed.It was reported that the physician did not have the distal end of the ruby coil introducer sheath wedged into the end of the hub of the lantern.It was also reported that the scrub technologist attempted to advance the ruby coil out of its introducer sheath on the back table but the coil would not advance.Therefore, the ruby coil was set aside and the procedure was completed using three other ruby coils and the same lantern.It should be noted that the physician did not use a rotating hemostasis valve (rhv) and did not use a continuous flush 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: 6892281
• Report Number: 3005168196-2017-01651
• Device Sequence Number: 750606
• Product Code: HCG
• UDI-Device Identifier: 00814548013091
• UDI-Public: 00814548013091
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 08/31/2017

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: 02/05/2025
• Device Catalogue Number: RBY2C2860
• Device Lot Number: F74306
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 09/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR