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

Model Number	RBYLP0310
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned ruby coil lp could not confirm the reported complaint due to the returned damage.Evaluation revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock, and the introducer sheath was kinked.Based on the reported complaint, this damage was incidental.During the functional test, the resistance was encountered while attempting to advance the pusher assembly mid-joint through the introducer sheath friction lock and the pusher assembly was kinked by the penumbra investigator, and no further functional testing was performed.Penumbra products 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coil lps.During the procedure, a ruby coil lp would not advance in the lantern, and the physician experienced resistance.Therefore, the ruby coil lp was removed.The procedure was completed using a new ruby coil lp and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the follow-up #01 mfr report and is being corrected on this follow-up #02 mfr report: 1.Section h.Box 6.Conclusions code 1.Section h box 6 (4316): the investigation findings do not lead to a clear conclusion about the root cause of the reported complaint due to the damage during the device investigation.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: 12627965
• Report Number: 3005168196-2021-02281
• Device Sequence Number: 1442980
• Product Code: HCG
• UDI-Device Identifier: 00815948021785
• UDI-Public: 00815948021785
• 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): 04/15/2022
• 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: 03/01/2025
• Device Model Number: RBYLP0310
• Device Catalogue Number: RBYLP0310
• Device Lot Number: F96599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• 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: 09/15/2021
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2020
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/01/2005