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

Model Number	RBY4C0305-B
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned ruby coil embolization coil confirmed that the embolization coil was detached from the pusher assembly.Further evaluation of the device revealed that the embolization coil had offset coil winds along its length.If the device is forcefully manipulated against resistance, damage such as this may occurred.The pusher assembly was not returned for evaluation and the functional testing could not be performed; therefore, the root cause of the resistance could not be determined.Evaluation of the returned ruby coil revealed that the pusher assembly was fractured, and a kink was observed near the fractured location.If the device is forcefully advanced against resistance, damage such as this may occur.If the pusher assembly is fractured, the pull wire will retract from the pusher assembly ddt and the embolization coil will detach from the pusher assembly.Further evaluation of the device revealed that the pusher assembly mid-joint was advanced distal to the introducer sheath fraction lock and the detached embolization coil was returned outside of the introducer sheath.Based on the returned condition, the reported ruby coil stuck in its initial position inside the introducer sheath could not be confirmed.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.This report is associated with mfr report number: 3005168196-2021-00994.
Event or Problem Description
The patient was undergoing a coil embolization in the left gastric artery and celiac artery using ruby coils, pod packing coils (pod pcs), a lantern delivery microcatheters (lantern), and 0.018 wire.It was reported the patient had a bleeding pseudo-aneurysm arising from the left gastric artery.During the procedure, the wire would not advance through the lantern smoothly.The lantern was removed, and the physician opened the second lantern.However right after, the physician was able to get the wire to advance smoothly by flushing the first lantern and wetting the wire and used this lantern in the procedure.The physician started with the ruby coil (f103831) which was found too large in diameter and kicked the lantern from the vessel.Subsequently, as the physician pulled the ruby coil, the ruby coil unintentionally detached inside the lantern.It was reported that the physician felt resistance while advancing and retracting the coil.Therefore, the lantern containing the detached ruby coil was removed.Subsequently, the physician decided to coil the origin of the vessel at the celiac artery, which they were able to access with ease and implanted the first ruby coil.Next, the physician followed up with the ruby coil (f84908) but had difficulty pushing the ruby coil past the friction lock as it was stuck at its initial position in the introducer sheath.The ruby coil was removed, and the physician implanted a second ruby coil and the first pod pc.The procedure ended at this point.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11795433
• Report Number: 3005168196-2021-00993
• Device Sequence Number: 19673583
• Product Code: HCG
• UDI-Device Identifier: 00814548018317
• UDI-Public: 00814548018317
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• 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
• Report Date (Section B): 04/11/2021
• 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 Model Number: RBY4C0305-B
• Device Catalogue Number: RBY4C0305
• Device Lot Number: F103831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• 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: 04/11/2021
• Initial Report FDA Received Date: 05/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005