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

Model Number	RBY4C0835-B
Medical Device Problem Code	Failure to Fold (1255)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2020
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: 3005168196-2020-00975, 3005168196-2020-00976.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left gonadal vein using ruby coils, pod packing coils and, lantern delivery microcatheter (lantern).During the procedure, while advancing a ruby coil into the target vessel, the physician noticed the ruby coil did not take it intended shape.It was reported that the physician retracted and repositioned the ruby coil multiple times; however, it was unsuccessful.Therefore, the ruby coil was removed, and a new ruby coil was successfully placed in the vessel.Next, while advancing another ruby coil through the microcatheter, the hospital technician noticed the pusher assembly of the ruby coil became kinked.Therefore, the ruby coil was removed.The physician then placed a new ruby coil.Afterwards, the hospital technician removed a pod pc from the packaging hoop and found the distal part of the pusher assembly to be kinked.Therefore, the pod pc was not used in the procedure.The physician placed a new pod pc in the vessel and while advancing another ruby coil through the lantern, the ruby coil unintentionally detached inside of the lantern.Therefore, the lantern was removed containing the detached ruby coil and the coil was flushed out.The procedure was completed using a new ruby coil and the same lantern.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: 10291926
• Report Number: 3005168196-2020-00974
• Device Sequence Number: 13686938
• Product Code: HCG
• UDI-Device Identifier: 00814548018386
• UDI-Public: 00814548018386
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• 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): 06/25/2020
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Model Number: RBY4C0835-B
• Device Catalogue Number: RBY4C0835
• Device Lot Number: F93209
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 07/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Date Report Sent to FDA: 01/01/2005