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

Model Number	RBY2C0930-A
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2020
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left subclavian artery using a ruby coil, a lantern delivery microcatheter (lantern), a non-penumbra diagnostic catheter and a non-penumbra vascular plug.During the procedure, the physician placed a vascular plug in the target vessel but there was still a lot of flow coming into the subclavian artery.Therefore, the physician decided to place a ruby coil.While advancing the ruby coil through the lantern and into the target vessel, the ruby coil would not seat in the vessel as there was a lot of flow coming through the vessel.It was reported that after pulling the ruby coil in and out of the vessel numerous times, the ruby coil appeared to be buckling inside the lantern.Attempts were also made to rapidly seat the ruby coil, but it was unsuccessful.Subsequently, physician decided to remove the ruby coil.However, while attempting to retract the ruby coil, the physician noticed that it had unintentionally detached inside the lantern.Therefore, the lantern and the diagnostic catheter were removed with the detached ruby coil.The procedure ended at this point.The patient will be brought back for thoracic endograft and possible coil embolization at a later date.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: 10722941
• Report Number: 3005168196-2020-01812
• Device Sequence Number: 3006407
• Product Code: HCG
• UDI-Device Identifier: 00814548012995
• UDI-Public: 00814548012995
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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): 09/28/2020
• 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 Expiration Date: 12/25/2025
• Device Model Number: RBY2C0930-A
• Device Catalogue Number: RBY2C0930
• Device Lot Number: F81167
• 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: 09/28/2020
• Initial Report FDA Received Date: 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Date Report Sent to FDA: 01/01/2005