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

Catalog Number	RBYLP0202
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure prostatic vessel using a ruby coil lp, lp system detachment handles (handle), and a non-penumbra microcatheter.During the procedure, the physician advanced a ruby coil lp to the target location using the microcatheter and attempted to detach it using a handle; however, the ruby coil lp failed to detach.The physician then attempted to detach the ruby coil lp using a forceps to pull the pusher assembly; however, the ruby coil lp still failed to detach.Therefore, the physician decided to remove the ruby coil lp.Subsequently, while retracting the ruby coil lp, the coil unintentionally detached in the middle of the microcatheter.Therefore, the physician removed the ruby coil lp pusher assembly and injected saline into the microcatheter to push the detached ruby coil lp into the vessel.The coil embolization part of the procedure was completed at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil lp confirmed that the embolization was detached from its pusher assembly.Evaluation revealed that the pet lock was separated, and the pull wire was retracted out of the ddt.This type of damage typically occurs during a successful detachment.The detached embolization coil was not returned for evaluation.Due to the returned condition, the root cause of the reported complaint could not be determined.Further evaluation revealed kinks along the pusher assembly.This damage was incidental to the reported complaint and the root cause could not be determined.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• 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: 14518254
• Report Number: 3005168196-2022-00232
• Device Sequence Number: 14828482
• Product Code: HCG
• UDI-Device Identifier: 00815948021747
• UDI-Public: 815948021747
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/26/2022
• 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 Expiration Date: 12/30/2025
• Device Catalogue Number: RBYLP0202
• Device Lot Number: F103075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2022
• 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: 05/02/2022
• Initial Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/31/2020
• 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: 68 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005