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

Model Number	RBY2C4060-B
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2020
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 number: 3005168196-2020-02119; 3005168196-2020-02120.
Event or Problem Description
The patient was undergoing a coil embolization procedure in an endoleak sac using ruby coils, pod packing coils (pod pc), a lantern delivery microcatheter (lantern), and non-penumbra diagnostic catheter.During the procedure, the physician placed the lantern through the diagnostic catheter.It was reported that the access was percutaneous and shallow.Consequently, when the physician experienced any resistance, the resistance would kick the diagnostic catheter out.While advancing a ruby coil through the lantern, the physician lost access to the sac and removed the entire system.Once on the back table, upon attempting to recapture the ruby coil, the pusher assembly of the ruby coil was inadvertently kinked.An attempt was made to straighten the pusher assembly, and the ruby coil broke.Subsequently, the physician continued with the procedure using a new ruby coil.Next, while advancing a pod pc through the lantern, the physician experienced resistance, and the lantern kinked, which caused the pod pc to became stuck in the lantern.The pod pc and lantern were removed.On the back table, while removing the pod pc from the lantern, the pod pc broke.Therefore, the pod pc and lantern were not used for the remainder of the procedure.The procedure was completed using a new pod packing coil and lantern, and the same diagnostic catheter.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: 10915332
• Report Number: 3005168196-2020-02118
• Device Sequence Number: 11527144
• Product Code: HCG
• UDI-Device Identifier: 00814548019437
• UDI-Public: 00814548019437
• Combination Product (Y/N): Y
• Initial Reporter State: RI
• 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): 11/02/2020
• 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: RBY2C4060-B
• Device Catalogue Number: RBY2C4060
• Device Lot Number: F96825
• 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: 11/02/2020
• Initial Report FDA Received Date: 11/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005