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

Catalog Number RBY2C1460

Device Problems Break (1069); Physical Resistance/Sticking (4012); Premature Separation (4045)

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

Event Date 11/06/2023

Event Type  malfunction  

Event Description

The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using ruby coils and a lantern delivery microcatheter (lantern).It should be noted that the patient¿s anatomy was mildly tortuous.During the procedure, the physician successfully implanted two ruby coils into the target vessel using the lantern.After flushing the lantern, the physician experienced resistance while advancing another ruby coil through the lantern.While attempting to retract the ruby coil, the ruby coil unintentionally detached within the lantern.The physician then attempted to push the detached ruby coil into the target vessel but was unsuccessful.Therefore, the physician decided to remove the lantern containing the ruby coil.Upon removal, the physician fractured the ruby coil pusher assembly.However, the lantern containing the ruby coil was successfully removed from the patient and the ruby coil was then removed from the lantern.The procedure was completed using three ruby coils, seven pod packing coils (pod pc), and the same lantern.There was no report of an adverse effect to the patient.

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.H3 other text : placeholder.

Manufacturer Narrative

Evaluation of the returned ruby coil confirmed that the embolization coil was detached.Evaluation of the ruby coil pusher assembly revealed a fracture, and the introducer sheath had multiple ovalizations.If the ruby coil is advanced against resistance, damage such as a pusher assembly kink may occur.Subsequent retraction against resistance likely worsened the kink to a fracture and caused the pull wire to retract, detaching the embolization coil.Based on the reported event, the root cause of resistance during the procedure could not be determined.The ovalizations on the introducer sheath were likely incidental to the complaint and the root cause could not be determined.Penumbra devices 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
• 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: 18350155
• MDR Text Key: 331073605
• Report Number: 3005168196-2023-00558
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548019116
• UDI-Public: 814548019116
• 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,Followup
• Report Date: 01/01/2005,01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBY2C1460
• Device Lot Number: F00007836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2023
• 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: 75 YR
• Patient Sex: Male