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

Model Number	RBYLP0630
Medical Device Problem Codes	Difficult to Advance (2920); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
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 gastroduodenal artery (gda) using ruby coil lps and a non-penumbra microcatheter.During the procedure, two ruby coil lps were successfully implanted into the target vessel and the microcatheter was subsequently flushed.While attempting to advance the next ruby coil lp, resistance was encountered, and the coil would not advance past its initial position within the introducer sheath.The physician continued making attempts to advance the ruby coil lp and it was eventually advanced into the microcatheter; however, the coil would not smoothly advance through the microcatheter.Therefore, the ruby coil lp was removed.The procedure was completed using a new ruby coil lp and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil lp revealed that the device was advanced from its starting position within the introducer sheath and coagulated blood and an unknown substance were within the introducer sheaths distal tip.Based on the reported complaint, this damage was likely incidental.During functional testing, the ruby coil lp could not be retracted from its returned position within the introducer sheath or advanced out of its introducer sheath due to the coagulated blood and unknown substance within the sheath; therefore, functional testing could not be performed, and the root cause of the inability to advance the coil through the microcatheter during the procedure could not be determined.Further evaluation of the device revealed bends throughout the pusher assembly.This damage was likely incidental to the 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 inability to advance the coil through the microcatheter.

• Brand Name: RUBY COIL LP
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11758056
• Report Number: 3005168196-2021-00914
• Device Sequence Number: 4138767
• Product Code: HCG
• UDI-Device Identifier: 00815948021860
• UDI-Public: 00815948021860
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2021
• 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: 09/13/2025
• Device Model Number: RBYLP0630
• Device Catalogue Number: RBYLP0630
• Device Lot Number: F100194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Date Report Sent to FDA: 01/01/2005