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

Model Number	RBYLP0304
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2021
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: 3005168196-2021-02479.3005168196-2021-02480.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coil lps and a microcatheter.During the procedure, three ruby coil lps would not advance at all past its initial position within its introducer sheath.Therefore, the three ruby coil lps were removed.The procedure was completed using additional ruby coil lps.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil lp revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance will likely be experienced during advancement and the device may not be advanced out of the introducer sheath.Forceful advancement against this resistance may have contributed to the fracture observed near the pusher assembly mid-joint.Due to the fracture, the device was unable to be functionally tested.Evaluation of the returned packing coil lp revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance will likely be experienced during advancement and the device may not be advanced out of the introducer sheath.During functional testing, the pusher assembly mid-joint was advanced through the introducer sheath friction lock with resistance.After the mid-joint passed through the friction lock, the packing coil lp was able to advance through its introducer sheath without an issue.Further evaluation of the device revealed a pusher assembly fracture.This damage was likely incidental to the complaint.Evaluation of the returned packing coil lp revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance will likely be experienced during advancement and the device may not be advanced out of the introducer sheath.Forceful advancement against this resistance may have contributed to the kink and fracture observed near the pusher assembly mid-joint.Due to the fracture, the device was unable to be functionally tested.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.This report is associated with mfr report number: 1.3005168196-2021-02479.2.3005168196-2021-02480.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the follow-up #01 mfr report and is being included on this follow-up #02 mfr report: 3005168196-2021-02478.1.Section h.Box 6.Result code 5: 114.This report is associated with mfr report number: 1.3005168196-2021-02479.2.3005168196-2021-02480.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: 12741121
• Report Number: 3005168196-2021-02478
• Device Sequence Number: 11794108
• Product Code: HCG
• UDI-Device Identifier: 00815948021778
• UDI-Public: 00815948021778
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/03/2022
• 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: 03/24/2026
• Device Model Number: RBYLP0304
• Device Catalogue Number: RBYLP0304
• Device Lot Number: F104887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• 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: 10/08/2021
• Supplement Date Received by Manufacturer: 11/05/2021; 01/14/2005
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 12/02/2021; 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2021
• 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