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

Catalog Number RBY2C0620

Device Problems Break (1069); Separation Failure (2547)

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

Event Date 11/05/2014

Event Type  malfunction  

Event Description

The patient was undergoing a coil embolization procedure in a gonadal vein using ruby coils.During the procedure, the physician was unable to detach a ruby coil.A ruby coil detachment handle was used and the pet lock was broken, yet the coil remained attached.The physician unsuccessfully attempted to detach the coil by manually pulling the proximal portion of the pullwire.The physician withdrew the ruby coil from the patient and the procedure continued using a new coil.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.

Manufacturer Narrative

Result: the ruby coil pusher assembly was fractured approximately 159.5 cm from the distal tip.The entire pull wire was removed from the pusher assembly.The ruby coil was detached from the pusher assembly.The ruby coil proximal constraint sphere outer diameter was measured within specification.The ruby coil distal detachment tip (ddt) inner diameter was measured within specification.The ruby coil pull wire was not returned.Conclusion: the complaint has been evaluated.The complaint indicates that the ruby coil did not detach while the physician was using a detachment handle.Evaluation of the returned product confirms that the coil was detached from the pusher assembly.It appears that due to the physician's efforts to get the coil to detach correctly, the coil was detached from the pusher.The proximal end of the pusher assembly and pull wire were not returned for evaluation.The components that are used to keep the coil intact, the proximal constraint sphere and ddt with the pusher assembly, were measured within specification.The tortuosity in the patient's vessel could have prevented the coil from detaching.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: 4303016
• MDR Text Key: 18271529
• Report Number: 3005168196-2014-00846
• 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,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: 02/28/2019
• Device Catalogue Number: RBY2C0620
• Device Lot Number: F41469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2015
• Initial Date FDA Received: 12/08/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2014
• 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