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

Catalog Number RBY4C0630

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2019

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

The patient was undergoing a coil embolization procedure to treat an inter-costal aneurysm using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician implanted a stent device in the thoracic part of the descending aorta to overcome a stenosis of the aorta.Next, the physician advanced the lantern through the meshes of the stent device and into the aneurysm.The physician then went further into the vessel and sacrificed it using three ruby coils.After that, the physician went backwards into the intercostal aneurysm and filled with two ruby coils.The physician then placed another ruby coil in the vessel and detached it using a ruby coil detachment handle (handle).It was reported that the ruby coil was not completely advanced out of the lantern and into the aneurysm when the detachment occurred and approximately seven centimeters of the ruby coil was still in the lantern.Therefore, the physician removed the lantern and tried to flush the remaining ruby coil out of the diagnostic catheter and into the aneurysm but it was unsuccessful.The physician then removed the diagnostic catheter and caught the part of the ruby coil that was hanging out of the aneurysm through the meshes of the stent device and into the aorta with a gooseneck snare device.It was reported that approximately five centimeters of the ruby coil that was hanging out of the aneurysm was removed from the patient and one to two centimeters of the ruby coil remained hanging out of the aneurysm.The procedure was then completed by over-stenting the one to two centimeters of the ruby coil with a new stent device.There was no report of an adverse effect to the patient.

• 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: 8761209
• MDR Text Key: 150121284
• Report Number: 3005168196-2019-01307
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013190
• UDI-Public: 00814548013190
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBY4C0630
• Device Lot Number: F87832
• Was Device Available for Evaluation?: No
• 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: 06/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2019
• 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: 47 YR
• Patient Weight: 80