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

Catalog Number RBY2C0320

Device Problems Premature Activation (1484); Retraction Problem (1536)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/17/2014

Event Type  malfunction  

Event Description

The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, a ruby coil unintentionally detached upon retraction.The ruby coil was successfully removed using syringe aspiration.There was no report of an adverse effect on the patient.

Manufacturer Narrative

Result: the coil was returned inside the introducer sheath and could not be removed.The coil was detached from the pusher assembly.The pet lock was intact on the proximal end of the pusher assembly indicating that the coil was not detached as intended.Conclusion: the complaint has been evaluated.The complaint indicates that the coil unintentionally detached while being retracted into the microcatheter.Evaluation of the returned product confirmed unintentional detachment from the coil pusher assembly.The coil was returned lodged inside the proximal end of the coil introducer sheath.It appears that during the retraction of the coil into the microcatheter and introducer sheath, the coil was pulled too far proximally and into the friction lock on the sheath, causing the proximal end of the coil to wedge inside the friction lock on the introducer sheath and the coil to detach due to excess force placed on the device during retraction.The maximum outer diameter of the coil is 0.022 and the inner diameter of the coil introducer sheath friction lock is 0.022.The coil should not be pulled this far proximal inside the introducer sheath.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: RUBY COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; 1351 harbor bay parkway; alameda, CA 94502 ; 5107483200
• MDR Report Key: 4337006
• MDR Text Key: 5219590
• Report Number: 3005168196-2014-00866
• Device Sequence Number: 1
• Product Code: HCG
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: RBY2C0320
• Device Lot Number: F60936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2014
• Initial Date FDA Received: 12/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2014
• 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: 56 YR