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

Catalog Number	RBY4C0860
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	09/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 in the hypogastric artery using a lantern delivery microcatheter (lantern), ruby coils, a pod packing coil (pod pc), a non-penumbra catheter and a guidewire ((b)(4)).During the procedure, the physician advanced the lantern through the catheter into the target location.The physician then attempted to advance the ruby coil through the lantern; however, the physician experienced resistance and the ruby coil would not advance through the lantern.The physician pulled the lantern back but the issue remained the same.After several attempts, the physician pulled the coil back; however, the ruby coil unintentionally detached inside the lantern.Therefore, the lantern and the ruby coil were removed.Upon removal, the distal end of the lantern was noticed to be kinked.Next, the physician placed non-penumbra coils distal to the target location.The physician then advanced a new lantern to the target location and successfully placed two ruby coils.After placing two ruby coils, the physician then attempted to advance the pod pc through the lantern; however, the physician experienced resistance and the pod pc would not exit the distal end of the lantern.Therefore, the lantern and the pod pc were removed.The physician decided to end the procedure 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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 17844670
• Report Number: 3005168196-2023-00443
• Device Sequence Number: 7173863
• Product Code: HCG
• UDI-Device Identifier: 00814548018393
• UDI-Public: 814548018393
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• 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
• Report Date (Section B): 09/29/2023
• 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 Catalogue Number: RBY4C0860
• Device Lot Number: F00006877
• Was Device Available for Evaluation?: No
• 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: 09/05/2023
• Initial Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2023
• 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 Age: 56 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Date Report Sent to FDA: 01/01/2005