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

Catalog Number RBY2C0312

Device Problems Detachment Of Device Component (1104); Failure to Fold (1255)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2018

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 product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report number: 3005168196-2018-01328.It's unknown if the device is available for return.

Event Description

The patient was undergoing a coil embolization procedure using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician successfully placed a ruby coil using a non-penumbra microcatheter.The physician then attempted to place another ruby coil in a different vessel, however, the ruby coil did not take its intended shape.It was reported that the ruby coil might have been too large.The physician therefore removed the ruby coil and switched to a lantern.The physician then attempted to place a smaller ruby coil using the lantern; however, the ruby coil did not take its intended shape.While attempting to remove the ruby coil, it unintentionally detached from the pusher assembly.The lantern was removed with the detached ruby coil inside and the procedure was completed using a new coil.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following sections were inadvertently missed on the initial mfr report and are being included on this follow-up #01 mfr report:3005168196-2018-01329.Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report:3005168196-2018-01329.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 number: 3005168196-2018-01328.

Event Description

"the patient was undergoing a coil embolization procedure in the renal branch using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician successfully placed a ruby coil using a non-penumbra microcatheter.The physician then attempted to place another ruby coil in a different vessel, however, the ruby coil did not take its intended shape.It was reported that the ruby coil might have been too large.The physician, therefore, removed the ruby coil and switched to a lantern.The physician then attempted to place a smaller ruby coil using the lantern, however, the ruby coil did not take its intended shape.While the physician was attempting to remove the ruby coil, the embolization coil unintentionally detached from the pusher assembly and, therefore, the lantern was removed with the ruby coil inside.The procedure was then completed using a new coil and a new lantern.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: 7659791
• MDR Text Key: 113270333
• Report Number: 3005168196-2018-01329
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): Y
• 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,Followup
• Report Date: 01/01/2005,06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: RBY2C0312
• Device Lot Number: F79974
• 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: 01/14/2005
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2017
• 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
• Patient Age: 72 YR