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

Model Number	RBYLP0204
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2021
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 number: 3005168196-2021-02086.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coil lps.During the procedure, two ruby coil lps would not advance out of the introducer sheaths.Therefore, they were removed.No additional information regarding the completion of the procedure was provided.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Evaluation of the returned ruby coil lp revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance will likely be experienced during advancement and the device may not advance out of the introducer sheath.During functional testing, the pusher assembly mid-joint was advanced through the introducer sheath friction lock with resistance, then additional resistance was experienced at the distal tip of the introducer sheath due to the unknown material inside the introduce sheath and the ruby coil lp was unable to advance through the introducer sheath.The unknown material inside the introducer sheath was likely incidental to the complaint.Further evaluation of the device revealed pusher assembly kink.This damage was likely incidental to the complaint and may have occurred during packaging for the device return.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: 3005168196-2021-02086 h3 other text : placeholder.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report.1.Section b.Box 5.Describe event or problem this report is associated with mfr report number: 3005168196-2021-02086 h3 other text : placeholder.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coil lps.During the procedure, two ruby coil lps would not advance out of the introducer sheaths.Therefore, they were removed.The procedure was completed using a new lp coil.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: 12496227
• Report Number: 3005168196-2021-02087
• Device Sequence Number: 16957787
• Product Code: HCG
• UDI-Device Identifier: 00815948021754
• UDI-Public: 00815948021754
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• 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,Followup
• Report Date (Section B): 07/29/2022
• 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: 05/16/2026
• Device Model Number: RBYLP0204
• Device Catalogue Number: RBYLP0204
• Device Lot Number: F106276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 10/19/2021; 01/14/2005
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 10/29/2021; 07/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2021
• 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 Age: 75 YR
• Patient Sex: Unknown
• Patient Weight: 77 KG
• Date Report Sent to FDA: 01/01/2005