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

Catalog Number RBYLP0210

Device Problem Premature Separation (4045)

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

Event Date 12/02/2022

Event Type  malfunction  

Event Description

The patient was undergoing a coil embolization procedure in the inferior upper gastric artery using ruby coil lps, lp system detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician advanced a penumbra coil into the target vessel and attempted to detach it using a handle; however, the coil failed to detach.Therefore, the physician removed the handle and used a new handle to detach the same coil.Next, while attempting to embolize the vessel, the physician noticed the ruby coil lp had unintentionally detached inside the microcatheter.Therefore, the physician used saline to flush the microcatheter and push the detached ruby coil lp into the vessel.Subsequently, while advancing another ruby coil lp through the microcatheter, the physician noticed the ruby coil lp started to take its intended shape within the microcatheter.Therefore, ruby coil lp was removed.The procedure was completed using additional ruby coil lps and the same microcatheter.There was no report of an adverse effect to the patient.

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.

Manufacturer Narrative

Evaluation of the returned ruby coil lp revealed offset coil winds on the embolization coil.This damage typically occurs due to advancement against resistance.The microcatheter used in the procedure is larger than intended to deliver a ruby coil lp.If the ruby coil lp is advanced through a microcatheter with a larger id than intended, resistance will likely be experienced.Based on the reported event, this is likely what contributed to the resistance experienced during the procedure and offset coil winds observed on the returned device.Further evaluation of the device revealed kinks on the pusher assembly.This damage was likely incidental to the complaint and may have occurred during packaging for the device return.Evaluation of the second returned ruby coil lp confirmed that the embolization coil was detached.Evaluation revealed that the pet lock was separated, and the pull wire was retracted.If the pet lock is separated and the pull wire retracted, the embolization coil will likely detach.This likely contributed to the reported coil detachment during the procedure.The detached embolization coil was not returned for evaluation.Further evaluation of the device revealed an ovalization on the introducer sheath.This damage was likely incidental to the complaint.Penumbra products 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.H3 other text : placeholder.

• 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: 16052428
• MDR Text Key: 306365687
• Report Number: 3005168196-2022-00589
• Device Sequence Number: 1
• Product Code: HCG
• 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: 01/01/2005,01/24/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: RBYLP0210
• Device Lot Number: F00002243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2022
• 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
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/27/2022
• Supplement Dates Manufacturer Received: 01/14/2005
• Supplement Dates FDA Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2022
• 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: 70 YR
• Patient Sex: Male