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

Model Number	RBY2C0530-A
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2021
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 gastroduodenal artery (gda) using ruby coils and a non-penumbra microcatheter.During the procedure, the physician successfully implanted one ruby coil in the target vessel.The physician then advanced the next ruby coil through the microcatheter; however, the ruby coil unintentionally detached inside the microcatheter.Therefore, the microcatheter containing the detached ruby coil was removed from the patient.The procedure was completed using additional ruby coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that this complaint was submitted to the fda by the user facility with the following reference number: (b)(4).The following section is being corrected on this follow-up report: 1.Section h8: usage of device.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12339718
• Report Number: 3005168196-2021-01831
• Device Sequence Number: 14697633
• Product Code: HCG
• UDI-Device Identifier: 00814548012919
• UDI-Public: 00814548012919
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2021
• 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: 04/26/2025
• Device Model Number: RBY2C0530-A
• Device Catalogue Number: RBY2C0530
• Device Lot Number: F75931
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Date Report Sent to FDA: 01/01/2005