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

Catalog Number	RBYLP0310
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using a ruby coil lp, an lp system detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician placed a ruby coil lp in the target location and attempted to detach it using the handle.It was reported that the black marker band of the ruby coil lp was separated; however, upon retracting the ruby coil lp, the physician noticed the coil was still attached to the pusher assembly.An attempt was made to manually break the back end of the ruby coil lp and remove the inner detachment wire, but the coil still would not detach.The physician then pulled back on the pusher assembly when the ruby coil lp unintentionally detached inside the microcatheter.Therefore, the physician used a syringe with saline to push the detached ruby coil lp into the target location and successfully implant the coil.It was also reported that the physician removed and switch to a new microcatheter.The procedure was completed using a pod coil, same handle, and a new microcatheter.There was no report of an adverse effect to the patient.
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.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #02 mfr report:3005168196-2023-00548.1.Section h.Box 3.''other'' reason for non-evaluation.

• 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: 18311277
• Report Number: 3005168196-2023-00548
• Device Sequence Number: 12331684
• Product Code: HCG
• UDI-Device Identifier: 00815948021785
• UDI-Public: 815948021785
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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,Followup
• Report Date (Section B): 12/20/2023
• 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: RBYLP0310
• Device Lot Number: F00002560
• 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: 11/17/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2022
• 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: 73 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005