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

Catalog Number	RBYLP0204
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the superior mesenteric artery (sma) using ruby coil lps, an lp system detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician advanced a ruby coil lp into the vessel and attempted to detach it using a handle; however, the ruby coil lp failed to detach.Therefore, the physician decided to remove the ruby coil lp.However, while retracting the coil, the physician noticed the ruby coil lp had unintentionally detached.It was reported that the detached ruby coil lp was partially in the microcatheter and partially inside the target location.The physician then used the pusher assembly of the ruby coil lp to push the detached portion of the coil that was in the microcatheter into the target vessel.It was also reported that the physician was able to push majority of the detached ruby coil lp into the target vessel; however, the proximal portion remained outside the vessel.The physician determined the proximal portion of the ruby coil lp that was outside the vessel was safe and decided to leave the coil in place.Next, the physician advanced another ruby coil lp into the vessel and attempted to detach it using the handle; however, this ruby coil lp also failed to detach.Subsequently, while retracting the ruby coil lp through the microcatheter to be removed, the coil had unintentionally detached.Therefore, the physician removed the microcatheter and then used a snare device to remove the detached ruby coil lp.The procedure was completed using a new ruby coil lp, the same handle and, same 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.This report is associated with mfr report number: 3005168196-2022-00310.

• 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: 14860848
• Report Number: 3005168196-2022-00309
• Device Sequence Number: 14843628
• Product Code: HCG
• UDI-Device Identifier: 00815948021754
• UDI-Public: 815948021754
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K192955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2022
• 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: RBYLP0204
• Device Lot Number: F110183
• 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: 06/05/2022
• Initial Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2021
• 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: 49 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005