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

Catalog Number RBY4C0860

Device Problem Premature Separation (4045)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/26/2024

Event Type  Injury  

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.

Event Description

The patient was undergoing a coil embolization procedure in the superficial femoral artery using ruby coils and a microcatheter.During the procedure, the physician advanced the ruby coil into the target location and reported that the coil was not taking its intended shape.The physician made several attempts to get the ruby coil to take its intended shape without success.The physician then observed under fluoroscopy that the ruby coil had unintentionally detached inside the patient''s vessel.Therefore, the ruby coil was removed using forceps and a snare device.The procedure was completed using and another ruby coil, a non-penumbra coil, a vascular plug, and the same microcatheter.

• 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: 18968925
• MDR Text Key: 338493445
• Report Number: 3005168196-2024-00104
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013213
• UDI-Public: 814548013213
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: K120330
• 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: 01/01/2005,03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBY4C0860
• Device Lot Number: F95602
• Was Device Available for Evaluation?: Yes
• 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: 02/27/2024
• Initial Date FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male