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

Model Number	RBY4C0835-A
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned ruby coil revealed pusher assembly bends and kinks, the pull wire was advanced distal to the pusher assembly ddt and the embolization coil was detached from the pusher assembly due to a fractured sr wire.Due to the return damage, the ruby coil could not be functionally tested; therefore, the root cause of the reported complaint could not be determined.Evaluation of the non-penumbra microcatheter revealed multiple ovalizations along its length.The microcatheter was used to complete the procedure; therefore, the damages observed on the microcatheter may be incidental to the complaint and may have occurred during packaging of the device for return to penumbra.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 splenic artery using ruby coils, pod coil, non-penumbra guide catheter, and a non-penumbra microcatheter.During the procedure, the physician advanced the microcatheter into the mid splenic and placed a pod coil.The microcatheter was then flushed and while advancing a ruby coil through the microcatheter, the hospital technologist started to experience resistance.Subsequently, the ruby coil was removed and inspected, the microcatheter was also re-flushed; however, when attempting to advance the same ruby coil through the microcatheter, the same issue occurred.Therefore, the ruby coil was removed.The procedure was completed using a new ruby coil and the same microcatheter.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: 11866817
• Report Number: 3005168196-2021-01126
• Device Sequence Number: 3508234
• Product Code: HCG
• UDI-Device Identifier: 00814548013206
• UDI-Public: 00814548013206
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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): 04/27/2021
• 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 Expiration Date: 10/02/2025
• Device Model Number: RBY4C0835-A
• Device Catalogue Number: RBY4C0835
• Device Lot Number: F79823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• 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: 04/27/2021
• Initial Report FDA Received Date: 05/21/2021
• 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