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

Model Number	RBYLP0860
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
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 numbers: 3005168196-2021-02746, 3005168196-2021-02748.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the portal vein using a packing coil lp, ruby coil lps and a non-penumbra microcatheter.During the procedure, while attempting to advance the packing coil lp into the microcatheter, the hospital technologist hand was holding the coil at the starting position of the introducer sheath and, consequently, the pusher assembly of the packing coil lp became bent.Therefore, the packing coil lp was removed.The hospital technologist then attempted to advance two ruby coil lps into the microcatheter; however, the same issue occurred.Therefore, the ruby coil lps were removed.The procedure was completed using additional lp coils, a lantern delivery microcatheter (lantern), and ruby coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned packing coil lp confirmed that the pusher assembly was kinked.This is likely the reported bend.Evaluation revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.Forceful advancement against this resistance likely contributed to the kink and fracture observed near the pusher assembly mid-joint.Due to the pusher assembly fracture, the packing coil lp could not be functionally tested.Evaluation of the first returned ruby coil lp confirmed that the pusher assembly was kinked.This is likely the reported bend.Evaluation revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.Forceful advancement against this resistance likely contributed to the kink and fracture observed near the pusher assembly mid-joint.Due to the pusher assembly fracture, the ruby coil lp could not be functionally tested.Evaluation of the second returned ruby coil lp confirmed that the pusher assembly was kinked.This is likely the reported bend.Evaluation revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.Forceful advancement against this resistance likely contributed to the kinks observed near the pusher assembly mid-joint.During the functional test, the ruby coil lp pusher assembly could not be advanced through the introducer sheath friction lock due to the kinks in the pusher assembly near the mid-joint and no further testing could be performed.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.Penumbra products are visually inspected during in-process inspection and during quality inspection after manufacturing.This report is associated with mfr report numbers: 1.3005168196-2021-02746.2.3005168196-2021-02748.

• 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: 12931059
• Report Number: 3005168196-2021-02747
• Device Sequence Number: 11988606
• Product Code: HCG
• UDI-Device Identifier: 00815948021884
• UDI-Public: 00815948021884
• Combination Product (Y/N): N
• 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): 01/07/2022
• 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: 10/01/2025
• Device Model Number: RBYLP0860
• Device Catalogue Number: RBYLP0860
• Device Lot Number: F100766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• 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: 11/09/2021
• Supplement Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 12/05/2021
• Supplement Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2020
• 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 Age: 68 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005