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

Catalog Number RBY2C1260

Device Problem Failure to Advance (2524)

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 of an aortic artery aneurysm using ruby coils.During the procedure, the physician was unable to advance two ruby coils into the microcatheter and they were not used.There was no report of an adverse effect on the patient.

Manufacturer Narrative

Conclusion: this device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This mdr is associated with mdr 3005168196-2014-00844.

Manufacturer Narrative

Result: the pusher assembly was kinked approximately 18.0 cm from the ddt, and kinked approximately 18.0 cm from the proximal end.The introducer sheath was kinked approximately 15.0 and 30.0 cm from the proximal end.The coil was stuck inside the introducer sheath.The od of the ddt was measured and found to be within product specifications.Conclusion: the complaint has been evaluated.The complaint indicated that during the procedure, the coils could not be advanced into a microcatheter.The coils were removed and the patient was not affected.Evaluation of the returned devices revealed in the first ruby coil, the pusher assembly was fractured and kinked, and the coil was kinked.Further evaluation revealed in the second ruby coil, the pusher assembly and introducer sheath were kinked.The type of damage found on both ruby coils typically occurs due to attempting to advance the device past resistance.In both ruby coils, the od of the ddt was measured within specification.The microcatheter used in the case was not returned and the model of the microcatheter was not reported in the complaint and, therefore, the root cause of the inability to advance the coils into the microcatheter cannot be determined.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: 4303023
• MDR Text Key: 5271824
• Report Number: 3005168196-2014-00845
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/05/2014

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: 07/31/2019
• Device Catalogue Number: RBY2C1260
• Device Lot Number: F44803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2015
• Initial Date FDA Received: 12/08/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2014
• 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