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

Catalog Number	RBY2C0435
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2019
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: 3005168196-2019-00397; 3005168196-2019-00398.
Event or Problem Description
The patient was undergoing a coil embolization procedure for a vessel sacrifice in the renal artery using ruby coils.During the procedure, the physician advanced initial ruby coils in the target vessel using a non-penumbra 4f guide catheter.While attempting to place another ruby coil in the target vessel, the ruby coil would not stay in place due to the high flow of the vessel.The physician then attempted to retract the ruby coil in order to reposition it; however, resistance was encountered and upon removal, it was noticed that the ruby coil had ¿knotted¿ on itself.The physician then continued the procedure by placing additional ruby coils using the same guide catheter.While attempting to place a new ruby coil in the target vessel, the ruby coil would not stay in place due to the high flow of the vessel.The physician then attempted to retract the ruby coil in order to reposition it; however, resistance was encountered and upon removal, it was noticed that the ruby coil had also ¿knotted¿ on itself.After that, the procedure continued using additional ruby coils.The physician then experienced resistance while attempting to advance a ruby coil through the guide catheter; therefore, the ruby coil was removed.The procedure was completed using other ruby coils and the same guide catheter.It should be noted that no microcatheter was used with the guide 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: 8382178
• Report Number: 3005168196-2019-00396
• Device Sequence Number: 11017831
• Product Code: HCG
• UDI-Device Identifier: 00814548012889
• UDI-Public: 00814548012889
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 01/31/2019
• 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: 04/11/2025
• Device Catalogue Number: RBY2C0435
• Device Lot Number: F75616
• 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: 01/31/2019
• Initial Report FDA Received Date: 03/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Date Report Sent to FDA: 01/01/2005