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

Catalog Number RBY2C2860

Device Problem Difficult to Advance (2920)

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

Event Date 11/04/2014

Event Type  malfunction  

Event Description

The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, the physician met resistance while advancing two ruby coils into the guide catheter.The coils were not inside the patient.They were removed and they were not used.

Manufacturer Narrative

Conclusion: the device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This mdr is associated with mdr 3005168196-2014-00841.

Manufacturer Narrative

Result: the ruby coil pusher assembly was kinked approximately 5.0 cm from the proximal end.The introducer sheath friction lock was distal of the mid-joint.There was a gap between the coil and the distal detachment tip (ddt).The ruby coil pusher assembly pet lock was intact on the proximal end of the pusher.Conclusion: the complaint has been evaluated.The complaint indicates that there was resistance and trouble getting the coil through a guide catheter.During the evaluation of the coil, it appears that the ruby coil 28x60 was slightly stretched and the proximal end of the pusher assembly hypo-tube was kinked.The cause of the resistance described by the physician was unknown.The coil could not be advance out of the introducer sheath into a penumbra microcatheter to see if the issue in the complaint could be recreated.It is also not known if the guide catheter that was being used was damaged.The kink in the proximal end of the pusher assembly and damage to the coil was likely due to the physician attempting to push the coil against resistance in the guide catheter.The cause of this complaint cannot be determined.These devices are 100% functional tested 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: 4298971
• MDR Text Key: 5190986
• Report Number: 3005168196-2014-00842
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/04/2014

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: 12/31/2018
• Device Catalogue Number: RBY2C2860
• Device Lot Number: F40273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2015
• Initial Date FDA Received: 12/04/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2013
• 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