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

Catalog Number	RBYLP0406
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2023
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.This report is associated with mfr report number: 1.3005168196-2023-00222.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat an endoleak in the lumbar artery to using ruby coil lps, an lp detachment handle system, and a microcatheter.It was reported that the patient¿s anatomy was tortuous.During the procedure, the physician advanced a ruby coil lp into the target location and attempted to detach the ruby coil lp with the handle; however, the ruby coil lp would not detach.Then, the physician attempted to manually detach the ruby coil lp without success.Next, while retracting the ruby coil lp, the ruby coil lp unintentionally detached within the microcatheter.Therefore, the physician used saline injection to push the ruby coil lp into the target location and used the pusher assembly to pack the ruby coil lp into position.Next, the same issue occurred with a second ruby coil.Therefore, the ruby coil lp was also implanted into the target location using saline injection and the pusher assembly to pack the ruby coil lp into position.The procedure was completed 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: 16928457
• Report Number: 3005168196-2023-00223
• Device Sequence Number: 6935105
• Product Code: HCG
• UDI-Device Identifier: 00815948021808
• UDI-Public: 815948021808
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K192955
• 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): 05/14/2023
• 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: 04/06/2026
• Device Catalogue Number: RBYLP0406
• Device Lot Number: F105235
• 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: 04/19/2023
• Initial Report FDA Received Date: 05/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2021
• 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 Sex: Female
• Date Report Sent to FDA: 01/01/2005