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

Model Number	RBYLP0204
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2021
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.This report is associated with mfr report numbers: 3005168196-2021-02055, 3005168196-2021-02056.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a fistula using ruby coil lps, ruby coils, a lp system detachment handle (handle), and non-penumbra microcatheter.During the procedure, the physician advanced a ruby coil lp through the microcatheter and attempted to detach the ruby coil lp.The ruby coil lp would not detach with the handle.Subsequently, the ruby coil lp was removed.A ruby coil was then advanced through the microcatheter, but the ruby coil became stuck in the microcatheter.Therefore, the ruby coil and microcatheter were removed.The procedure was completed using new ruby coils, a ruby coil detachment handle (handle), and a new non-penumbra microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil lp revealed that the pet lock was intact on the proximal end of the pusher assembly and the pull wire was within its initial position inside the ddt.If a detachment handle is not properly inserted on the proximal end of the ruby coil lp during the procedure, the pet lock may not separate when the handle is actuated, and the pull wire may not retract from the ddt to detach the embolization coil.Further evaluation of the device revealed kinks throughout the pusher assembly, offset coil winds along the length of the embolization and coagulated blood within the ddt.These damages were likely incidental to the complaint.Due to the coagulated blood inside the ddt, the pull wire was unable to be retracted from the ddt and the ruby coil lp was unable to be detached with a demonstration handle during functional testing.Evaluation of the returned ruby coil could not confirm the reported complaint.During functional testing, the ruby coil was able to advance through a demonstration introducer sheath and a demonstration lantern without an issue.The root cause of the coil getting stuck during the procedure could not be determined.Further evaluation of the device revealed a kink on its pusher assembly and offset coil winds on the embolization coil.This damage was likely incidental to the complaint.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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of detachment issue.This report is associated with mfr report numbers: 1.3005168196-2021-02055, 2.3005168196-2021-02056.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: 12478063
• Report Number: 3005168196-2021-02054
• Device Sequence Number: 4892641
• Product Code: HCG
• UDI-Device Identifier: 00815948021754
• UDI-Public: 00815948021754
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 11/09/2021
• 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: 07/05/2025
• Device Model Number: RBYLP0204
• Device Catalogue Number: RBYLP0204
• Device Lot Number: F98706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• 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: 08/23/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2020
• 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: Male
• Date Report Sent to FDA: 01/01/2005