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

Catalog Number	RBY2C0530
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2019
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 number: 3005168196-2019-00195; 3005168196-2019-00196; 3005168196-2019-00198; 3005168196-2019-00199.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat arteriovenous (av) fistulas in the patient¿s leg using ruby coils and a lantern delivery microcatheter (lantern).It should be noted that the vessels were difficult to access.During the procedure, the physician successfully positioned a guidewire, non-penumbra catheter, and a lantern into the target vessel and deployed four ruby coils.The technician then felt resistance while advancing the fifth ruby coil and was only able to advance 90% of the coil into the lantern before the ruby coil became kinked.The ruby coil was therefore removed.While advancing the sixth ruby coil, the technician again felt resistance and same issue occurred.The sixth ruby coil was, therefore, removed.The lantern was then removed from the patient and inspected.It was reported that there was no issue with the lantern and no visible damage; however, the lantern was set aside and a new lantern was used to continue the procedure.The same guidewire and the same non-penumbra catheter were also used.The physician then decided to re-position the guidewire, non-penumbra catheter, and new lantern together in order to regain access to the target vessel.However, while advancing the seventh ruby coil through the lantern, the physician felt resistance and noticed that the ruby coil became kinked.The seventh ruby coil was then removed.The eighth ruby coil was then advanced within the lantern, but the same issue occurred.The eighth ruby coil and the lantern were then removed from the patient.Upon removal, the physician found that the lantern was kinked 2 cm from the distal end and the lantern was no longer used in the procedure.The procedure was completed using another lantern and two additional ruby coils.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: 8313263
• Report Number: 3005168196-2019-00197
• Device Sequence Number: 14025299
• Product Code: HCG
• UDI-Device Identifier: 00814548012919
• UDI-Public: 00814548012919
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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): 01/08/2019
• 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: 03/10/2026
• Device Catalogue Number: RBY2C0530
• Device Lot Number: F82254
• 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: 01/08/2019
• Initial Report FDA Received Date: 02/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Date Report Sent to FDA: 01/01/2005