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

Model Number	RBYLP0105
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the polypectomy site using ruby coil lps and a lp system detachment handle (handle).During the procedure, a ruby coil lp would not detach after placement.After several attempts, the coil was removed.The procedure was completed using a new ruby coil lp and the same handle.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil lp revealed that the pet lock was separated but the pull wire was not retracted on the proximal end of the pusher assembly, and the embolization coil was intact with the pusher assembly.During functional testing, the proximal end of the ruby coil lp¿s pusher assembly was inserted into a demonstration handle and the handle was actuated; subsequently, the pusher assembly began to bunch throughout the distal shaft, and the embolization coil did not detach.The root cause of this damage could not be determined.Further evaluation revealed pusher assembly bends on its proximal shaft, the introducer sheath was loaded backwards onto the ruby coil lp and the embolization coil had offset coil winds.This damage was likely incidental to the reported complaint.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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of detachment issue.

• Brand Name: RUBY COIL LP
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11958187
• Report Number: 3005168196-2021-01274
• Device Sequence Number: 13797173
• Product Code: HCG
• UDI-Device Identifier: 00815948021730
• UDI-Public: 00815948021730
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K192955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2021
• 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: 12/30/2025
• Device Model Number: RBYLP0105
• Device Catalogue Number: RBYLP0105
• Device Lot Number: F103074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Date Report Sent to FDA: 01/01/2005