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

Model Number	RBY2C0725-A
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2021
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left hypogastric artery using pod coils, ruby coils, and a lantern delivery microcatheter (lantern).During the procedure, a pod coil was advanced to the target vessel; however, the pod coil was determined to be too small.Therefore, the pod coil was removed intact.Then, the physician advanced a ruby coil to the target vessel; however, the ruby coil was also determined to be too small.Therefore, the ruby coil was removed and saved for later use.The physician then successfully implanted another pod coil in the target vessel.Next, the physician re-advanced the previously removed ruby coil to the target vessel; however, the ruby coil was determined to be too small again.Therefore, the ruby coil was re-sheathed.The physician then successfully implanted another ruby coil in the targe vessel.While attempting to re-advance the previously removed ruby coil through the lantern a third time, the ruby coil unintentionally detached in the lantern.Therefore, the lantern containing the detached ruby coil was removed from the patient.The procedure was completed using another ruby coil and the same lantern.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: 12052463
• Report Number: 3005168196-2021-01400
• Device Sequence Number: 4304420
• Product Code: HCG
• UDI-Device Identifier: 00814548012957
• UDI-Public: 00814548012957
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• 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): 06/23/2021
• 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: 01/05/2024
• Device Model Number: RBY2C0725-A
• Device Catalogue Number: RBY2C0725
• Device Lot Number: F67224
• 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: 05/26/2021
• Initial Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Date Report Sent to FDA: 01/01/2005