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

Catalog Number	RBYLP0310
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
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 left hepatic artery using ruby coils, ruby coil lps, a pod coil, a lp detachment handle (handle), a non-penumbra microcatheter, and a guidewire.During the procedure, the physician successfully implanted one pod coil.It was reported the patient¿s anatomy was tortuous.The physician then advanced a ruby coil using the microcatheter into the target vessel and attempted to detach the ruby coil using the handle; however, the ruby coil failed to detach.The physician attempted to manually detach the coil without success.Therefore, the ruby coil was removed.Subsequently, the same issue occurred with the next ruby coil lp.Therefore, the ruby coil lp was removed.Next, the physician advanced a new ruby coil lp into the target vessel and attempted to detach it using the handle; however, the ruby coil lp would not detach.The physician attempted to manually detach the coil without success.Therefore, the physician decided to remove the microcatheter and the ruby coil lp.Consequently, the ruby coil lp unintentionally detached in the right hepatic artery.Therefore, the physician attempted to use a snare device to remove the coil; however, it was unsuccessful.The ruby coil lp was left in the artery.The procedure ended at this point.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL LP
• 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: 16704207
• Report Number: 3005168196-2023-00161
• Device Sequence Number: 19740014
• Product Code: HCG
• UDI-Device Identifier: 00815948021785
• UDI-Public: 815948021785
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K192955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/07/2023
• 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 Expiration Date: 02/15/2026
• Device Catalogue Number: RBYLP0310
• Device Lot Number: F103903
• 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: 03/14/2023
• Initial Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2021
• 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: 66 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005