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

Model Number	RBYLP0406
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the first returned ruby coil lp revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.Forceful advancement against this resistance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 observed near the mid-joint.During functional testing, the pusher assembly mid-joint was advanced through the introducer sheath friction lock with resistance.Then, the ruby coil lp was advanced through the rest of the introducer sheath without an issue.Further evaluation revealed additional pusher assembly kinks.This damage was likely incidental to the reported complaint.Evaluation of the second returned ruby coil lp revealed that the pusher assembly had multiple kinks and was fractured, the pusher assembly mid-joint was retracted through the introducer sheath friction lock, the introducer sheath was stretched and fractured on the pusher assembly, and the embolization coil was detached from the pusher assembly.Due to the return damage, the reported complaint could not be confirmed, and the root cause could not be determined.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: 3005168196-2021-02707.
Event or Problem Description
The patient was undergoing a coil embolization procedure in a branch off the ovarian vein using ruby coil lps.During the procedure, two ruby coil lps would not advance at all past their initial positions within their introducer sheaths.Therefore, the 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Evaluation of the first returned ruby coil lp revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.Forceful advancement against this resistance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 observed near the mid-joint.During functional testing, the pusher assembly mid-joint was advanced through the introducer sheath friction lock with resistance.Then, the ruby coil lp was advanced through the rest of the introducer sheath without an issue.Further evaluation revealed additional pusher assembly kinks.This damage was likely incidental to the reported complaint.Evaluation of the second returned ruby coil lp revealed that the pusher assembly had multiple kinks and was fractured, the pusher assembly mid-joint was retracted through the introducer sheath friction lock, the introducer sheath was stretched and fractured on the pusher assembly, and the embolization coil was detached from the pusher assembly.Due to the return damage, the reported complaint could not be confirmed, and the root cause could not be determined.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in a branch off the ovarian vein using ruby coil lps.During the procedure, two ruby coil lps would not advance at all past their initial positions within their introducer sheaths.Therefore, the 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.

• 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: 12901456
• Report Number: 3005168196-2021-02707
• Device Sequence Number: 3948344
• Product Code: HCG
• UDI-Device Identifier: 00815948021808
• UDI-Public: 00815948021808
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 11/30/2021
• 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: 09/02/2025
• Device Model Number: RBYLP0406
• Device Catalogue Number: RBYLP0406
• Device Lot Number: F99995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• 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: 11/05/2021
• Initial Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2020
• 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: 15 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005