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

Catalog Number RBY2C2860

Device Problems Bent (1059); Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 06/11/2018

Event Type  malfunction  

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.This report is associated with mfr report numbers: 3005168196-2018-01348, 3005168196-2018-01349.The hospital disposed of the device.

Event Description

The patient was undergoing coil embolization to treat an abdominal aortic aneurysm endoleak (aaa endoleak) using ruby coils and a ruby coil detachment handle (handle).During the procedure, the physician deployed two ruby coils in the target vessel and used a handle to detach the coils.The physician then advanced another ruby coil in the target vessel and used the handle to detach it; however, the ruby coil failed to detach completely.It was reported that the handle was not making the same clicking sound.Therefore, the physician opened a new handle and successfully detached the ruby coil.Next, the hospital technologist, bent and broke a ruby coil pusher assembly on the back table while removing the ruby coil out of the dispenser hoop.Therefore, the ruby coil was set aside and the procedure was completed using another ruby coil and the second handle.

• 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: 7665112
• MDR Text Key: 113283656
• Report Number: 3005168196-2018-01350
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013091
• UDI-Public: 00814548013091
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Catalogue Number: RBY2C2860
• Device Lot Number: F78867
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2017
• 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