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

Catalog Number	RBY4C2060
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2019
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: 3005168196-2019-01428, 3005168196-2019-01429, 3005168196-2019-01431, 3005168196-2019-01432.
Event or Problem Description
The patient was undergoing a embolization procedure in the popliteal artery using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician made a direct stick into the patient's anatomy, and attempted to advance a ruby coil through a non-penumbra catheter, while advancing the ruby coil, it became stuck within the non-penumbra microcatheter; therefore, the ruby coil was removed and re-sheathed.The non-penumbra microcatheter was then re-positioned and the physician attempted again to advance the same ruby coil; however, the coil would not advance out of its introducer sheath; therefore, the ruby coil was then removed and not used in the procedure.The physician attempted to advance a new ruby coil with the same non-penumbra microcatheter, but same issue occurred; therefore, the coil was removed.The physician re-positioned the non-penumbra microcatheter and attempted to advance a third ruby coil; however, it became stuck in the non-penumbra microcatheter; therefore, the non-penumbra microcatheter and ruby coil were removed.The physician then advanced a lantern delivery microcatheter (lantern) and successfully placed 15 ruby coils without an issue.However, while advancing the 16th and final ruby coil, the physician experienced resistance and the coil became stuck approximately three inches into the proximal portion of the lantern; the ruby coil was then retracted several times, but it would not advance past the resistance in the lantern; therefore, the ruby coil and lantern were removed.The procedure was ended after removal of the final ruby coil as the physician was satisfied with the result obtained with the other ruby coils.There was no report of an adverse effect to patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8826511
• Report Number: 3005168196-2019-01430
• Device Sequence Number: 226908
• Product Code: HCG
• UDI-Device Identifier: 00814548013251
• UDI-Public: 00814548013251
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/25/2019
• 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: 03/31/2026
• Device Catalogue Number: RBY4C2060
• Device Lot Number: C10968
• 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: 06/25/2019
• Initial Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Date Report Sent to FDA: 01/01/2005