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

Catalog Number RBYLP0415

Device Problems Failure to Advance (2524); Premature Separation (4045)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2022

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using ruby coil lps and a non-penumbra microcatheter.During the procedure, the physician was unable to advance a ruby coil lp through the distal end of the microcatheter and into the target vessel.Therefore, the ruby coil lp was removed.The physician then attempted to advance a new ruby coil lp into the vessel; however, the same issue occurred.Consequently, the physician was manipulating the ruby coil lp when the coil unintentionally detached inside the microcatheter.Therefore, the physician used saline to push the detached ruby coil lp into the vessel.Subsequently, the physician advanced the next ruby coil lp, but the coil would not advance past the distal end of the microcatheter again; therefore, both the ruby coil lp and microcatheter was removed.The procedure was completed using ruby coils and a lantern delivery microcatheter (lantern).There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned ruby coil lp pusher assembly confirmed that the embolization coil was detached.Evaluation revealed a fracture on the pusher assembly.If the ruby coil lp is manipulated against resistance during use, damage such as a kink and subsequent fracture on the pusher assembly may occur.This damage likely contributed to the embolization coil detachment.The damage observed on the returned non-penumbra microcatheter likely contributed to the resistance during the procedure.Further evaluation of the device revealed kinks throughout the pusher assembly.Based on the returned condition, this damage was likely incidental to the complaint and likely occurred during packaging for the device return.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
• Type of Device: 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: 15794451
• MDR Text Key: 305289198
• Report Number: 3005168196-2022-00524
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00815948021815
• UDI-Public: 815948021815
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192955
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBYLP0415
• Device Lot Number: F113018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male