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

Catalog Number	RBYLP0204
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the prostate artery using a ruby coil lp, a non-penumbra microcatheter, and a guidewire.It was reported that the patient¿s anatomy was tortuous.During the procedure, while advancing a ruby coil lp through the microcatheter, the ruby coil lp unintentionally detached within the microcatheter, therefore, the microcatheter containing the detached ruby coil lp was removed from the patient and the microcatheter was flushed.The procedure was completed using a new ruby coil lp and a new non-penumbra microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was sent out for return; however, has not been received by the manufacturer.Therefore, 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.Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report:3005168196-2024-00210.

• Brand Name: RUBY COIL LP
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 19431964
• Report Number: 3005168196-2024-00210
• Device Sequence Number: 18199613
• Product Code: HCG
• UDI-Device Identifier: 00815948025981
• UDI-Public: 00815948025981
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K230284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2024
• 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 Catalogue Number: RBYLP0204
• Device Lot Number: F00009589
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 05/09/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 05/30/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005