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

Catalog Number	RBY2C0630
Medical Device Problem Codes	Migration (4003); Premature Separation (4045)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.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 gastroduodenal artery (gda) using a ruby coil, a ruby coil detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician thought that the entire ruby coil was placed in the target location using the handle; however, while removing the microcatheter, the physician noticed that the ruby coil had unintentionally detached within the microcatheter.The physician decided to remove the microcatheter containing the detached ruby coil.While removing, the ruby coil migrated to a branch in the gda.No attempts were made to remove the detached ruby coil.The coil embolization procedure ended at this point.The patient was brought back on (b)(6) 2024 for a radioembolization (y90) procedure.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report:3005168196-2024-00150 1.Section b.Box 5.Describe event or problem 2.Section h.Box 6.Device code 1 & device code 2 evaluation of the returned ruby coil revealed that the embolization coil was detached from its pusher assembly, the pusher assembly was kinked and fractured.The distal fractured segment of the pusher assembly was not returned for evaluation.This damage was incidental to the reported complaint.The root cause of the pusher assembly fracture could not be determined.The root cause of the difficulty experienced while detaching during the procedure could not be determined.The kinks likely occurred during packaging of the device for return to penumbra.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.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 a ruby coil, a ruby coil detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician thought that the entire ruby coil was placed in the target location using the handle; however, while removing the microcatheter, the physician noticed that the ruby coil had detached within the microcatheter.The physician decided to remove the microcatheter containing the detached ruby coil.While removing, the ruby coil migrated to a branch in the gda.No attempts were made to remove the detached ruby coil.The coil embolization procedure ended at this point.The patient was brought back on (b)(6) 2024 for a radioembolization (y90) procedure.

• Brand Name: RUBY COIL
• 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: 19149587
• Report Number: 3005168196-2024-00150
• Device Sequence Number: 7443884
• Product Code: HCG
• UDI-Device Identifier: 00814548018812
• UDI-Public: 814548018812
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• 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): 05/20/2024
• 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: RBY2C0630
• Device Lot Number: F00006135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2024
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2023
• 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: Other
• Patient Age: 76 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005