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

Catalog Number	RBYLP0860
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/21/2024
Type of Reportable Event	Serious Injury
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.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat an endoleak using a ruby coil lp and a non-penumbra microcatheter.It was reported that the pusher wire of the ruby coil lp was slightly kinked.During the procedure, while advancing the ruby coil lp through the microcatheter, the ruby coil lp unintentionally detached in the patient's vessel.Therefore, the physician used a snare device to remove the ruby coil lp.The procedure was completed using a new coil (unknown) and the same microcatheter.

• 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 ; 510748-3200
• MDR Report Key: 18899244
• Report Number: 3005168196-2024-00082
• Device Sequence Number: 6410938
• Product Code: HCG
• UDI-Device Identifier: 00815948026117
• UDI-Public: 815948026117
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K192955
• 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
• Report Date (Section B): 03/13/2024
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: RBYLP0860
• Device Lot Number: F00008825
• 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: 02/21/2024
• Initial Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005