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

Catalog Number RBY4C1035

Device Problems Material Deformation (2976); Physical Resistance/Sticking (4012); Premature Separation (4045)

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

Event Date 09/21/2022

Event Type  malfunction  

Event Description

The patient was undergoing a coil embolization procedure in the femoral artery using ruby coils, a lantern delivery microcatheter (lantern), and an angiographic catheter.It should be noted that the patient's anatomy was tortuous.During the procedure, the physician successfully implanted three ruby coils into the target location.While advancing the next ruby coil through the middle of the lantern, resistance was encountered, the coil became stuck, and the pusher assembly kinked.Upon retraction, the ruby coil stretched and unintentionally detached inside the lantern.Therefore, the lantern containing the detached ruby coil was removed.At this point, angiography showed that bleeding had stopped and the procedure was ended.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned ruby coil confirmed that the embolization coil was detached.Evaluation revealed that the pusher assembly was fractured, and the pull wire was retracted at the fractured location.If the ruby coil is advanced against resistance at an extreme angle during use, damage such as a kink and subsequent fracture on the pusher assembly may occur.If the pusher assembly is fractured and separated, the pull wire will retract from the pusher assembly ddt.This likely contributed to the embolization coil detachment during the procedure.The root cause of the resistance could not be determined.Evaluation also confirmed that the embolization coil had offset coil winds and introducer sheath was kinked near its proximal end.Based on the reported event, this damage likely occurred due to manipulation of the device against resistance during the procedure.Further evaluation revealed that the pet lock was separated, the pull tube was retracted, and the pusher assembly was kinked.This damage was likely incidental to the complaint.Penumbra coils are visually inspected during in-process inspection and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.Placeholder.

• Brand Name: RUBY COIL
• 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: 15650486
• MDR Text Key: 307109515
• Report Number: 3005168196-2022-00484
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548018669
• UDI-Public: 814548018669
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBY4C1035
• Device Lot Number: F112279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2022
• 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: 09/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2022
• 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