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

Catalog Number RBY4C0630

Device Problem Kinked (1339)

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

Event Date 11/28/2014

Event Type  malfunction  

Event Description

The patient was undergoing a coil embolization procedure using a ruby coil.During preparation for the procedure, a kink was noted in the pusher.The coil was not used in the procedure and a new one was used to complete the procedure.

Manufacturer Narrative

Conclusion: this device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Manufacturer Narrative

Result: the pet lock was intact on the proximal end of the pusher assembly; the pusher assembly was kinked approximately 5.0 and 109.0 cm from the proximal end, and the coil was intact with the pusher assembly.Conclusion: the complaint has been evaluated.The complaint indicated that the doctor lifted the pusher assembly from the rubber grip as per correct handling guidance, and immediately noticed a kink in the pusher just in front of the black detachment marker band.Evaluation of the returned device revealed that the pusher assembly was damaged.This type of damage typically occurs if the product was improperly handled during the removal from the package.If force is applied on the pusher assembly while maneuvering the device, it is likely that damage such as this may occur.These devices are 100% functionally tested and visually inspected during process inspection.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: 4354147
• MDR Text Key: 5220866
• Report Number: 3005168196-2014-00912
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2014

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: 06/30/2019
• Device Catalogue Number: RBY4C0630
• Device Lot Number: F44429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2015
• Initial Date FDA Received: 12/22/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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