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

Catalog Number	RBYLP0202
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastric artery using ruby coil lps and a non-penumbra microcatheter.During the procedure, while advancing the ruby coil lp through the microcatheter, the physician experienced resistance.Therefore, the ruby coil lp was removed.The physician then advanced a new ruby coil lp into the microcatheter; however, resistance was encountered within the microcatheter.Subsequently, while retracting, the physician was still experiencing resistance and the ruby coil lp unintentionally detached inside the microcatheter.It was reported that the ruby coil lp was successfully removed out from the microcatheter.The procedure was completed using a non-penumbra coil and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil lp confirmed that the embolization coil was detached.Evaluation revealed that the pet lock was separated, and the pull wire was retracted from the pusher assembly.If the pet lock is inadvertently mishandled during the retraction of the device from the microcatheter, the pet lock may separate, and the pull wire may retract from the distal tip of the pusher assembly.This likely contributed to the reported embolization coil detachment during the procedure.The detached embolization coil was not returned for evaluation.Due to the returned condition, the ruby coil lp could not be functionally tested for the reported advancement issue; therefore, the root cause of the reported resistance experienced during advancement could not be determined.Further evaluation revealed that the pusher assembly was kinked throughout its length.This damage was likely incidental to the complaint and likely occurred during packaging for the device return.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.H3 other text : placeholder.

• 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: 16828514
• Report Number: 3005168196-2023-00204
• Device Sequence Number: 20614212
• Product Code: HCG
• UDI-Device Identifier: 00815948021747
• UDI-Public: 815948021747
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Followup
• Report Date (Section B): 05/16/2023
• 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: RBYLP0202
• Device Lot Number: F111519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2023
• 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: 04/06/2023
• Supplement Date Received by Manufacturer: 05/01/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2021
• 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: 69 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005