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

Model Number	RH1-A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2021
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.This report is associated with mfr report number: 3005168196-2021-02527.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the renal artery using ruby coils, a ruby coil detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician advanced a ruby coil to the target vessel and attempted to detach it using the handle; however, the ruby coil failed to detach.Therefore, the physician manually detached the ruby coil.The physician then advanced another ruby coil to the target vessel and successfully detached it using the handle.However, after the detachment, the pusher assembly of the ruby coil became stuck in the handle.Therefore, the handle was not used for the remainder of the procedure.It was reported that the handle was unable to fully cover the pusher assemblies of the ruby coils and that the physician experienced resistance while advancing the pusher assemblies of the ruby coils into the handle.The procedure was completed using a new handle and additional ruby coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned handle and ruby coil pusher assembly confirmed, that the ruby coil¿s pull tube was stuck within the handle.If the handle is repeatedly actuated, during attempts to detach the coil, damage such as this may occur.The pull tube and pull wire were able to be removed from the handle body after disassembling the handle.The handle was then tested on a test fixture and performed within specification.Subsequently, the handle was used to detach a demonstration ruby coil without an issue.Further evaluation of the ruby coil pusher assembly revealed, bends and kinks.This damage was likely incidental to the reported complaint.Penumbra handles are 100% visually inspected and functionally tested, during incoming quality inspection.Penumbra coils are 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.This report is associated with mfr report number: 1.3005168196-2021-02527.H3 other text: placeholder.

• Brand Name: RUBY COIL DETACHMENT HANDLE
• 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: 12778943
• Report Number: 3005168196-2021-02526
• Device Sequence Number: 12199650
• Product Code: HCG
• UDI-Device Identifier: 00814548013268
• UDI-Public: 00814548013268
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2021
• 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: 04/05/2024
• Device Model Number: RH1-A
• Device Catalogue Number: RH1
• Device Lot Number: F105169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• 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: 10/14/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2021
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/01/2005