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

Model Number	RBY4C2060-B
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
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: 3005168196-2021-00337, 3005168196-2021-00339, 3005168196-2021-00340, 3005168196-2021-00341.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left subclavian artery using ruby coils, a lantern delivery microcatheter (lantern), and a sheath.During the procedure, the first ruby coil would not advance past the middle of the lantern.Therefore, the ruby coil was removed.Subsequently, two ruby coils were successfully implanted into the target location.Next, two ruby coils would not advance past the middle of the lantern.Therefore, these ruby coils were removed.The physician decided to remove the lantern and, upon removal, the physician noticed the lantern was kinked proximal to the hub.Therefore, the lantern was no longer used in the procedure.The physician used a new lantern to successfully implant one ruby coil.However, the next ruby coil would not advance past the distal end of the lantern.Therefore, the ruby coil was removed.The procedure was completed using the same lantern, another ruby coil, and the same sheath.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: 11376173
• Report Number: 3005168196-2021-00338
• Device Sequence Number: 3996471
• Product Code: HCG
• UDI-Device Identifier: 00814548019123
• UDI-Public: 00814548019123
• 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): 01/26/2021
• 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: RBY4C2060-B
• Device Catalogue Number: RBY4C2060
• Device Lot Number: F87445
• 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: 01/26/2021
• Initial Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 82
• Date Report Sent to FDA: 01/01/2005