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

Model Number	RBYLP0406
Medical Device Problem Codes	Failure to Advance (2524); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2021
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) branch using ruby coil lps.During the procedure, a ruby coil lp would not advance from the starting position of introducer sheath, and the pusher assembly of the coil became bent.Therefore, the ruby coil lp was removed.The procedure was completed using a new ruby coil lp.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil lp confirmed that the pusher assembly was kinked.If the pusher assembly is forcefully advanced against resistance, damage such as a kink may occur.Further evaluation of the returned ruby coil lp revealed that the pet lock was intact on the proximal of the pusher assembly, the embolization coil was detached from its pusher assembly, and the braided shaft was undamaged on the distal shaft of the pusher assembly.This damage was incidental to the reported complaint.The root cause of the reported advancement issue from the starting position could not be determine.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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of failure in advancing.

• Brand Name: RUBY COIL LP
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11285443
• Report Number: 3005168196-2021-00222
• Device Sequence Number: 11631783
• Product Code: HCG
• UDI-Device Identifier: 00815948021808
• UDI-Public: 00815948021808
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• 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): 01/11/2021
• 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: 02/26/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Date Report Sent to FDA: 01/01/2005