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

Catalog Number RBY2C2060

Device Problem Premature Activation (1484)

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 in the hypogastric artery using ruby coils.During the procedure, a ruby coil unintentionally detached within the microcatheter (non-penumbra device) and was successfully removed.There was no report of an adverse effect on the patient.

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.

Manufacturer Narrative

Result: the ruby coil was detached from the pusher assembly.The outer diameter of the coil, and proximal constraint sphere were measured and found to be within specification.Conclusion: the complaint has been evaluated.The complaint indicated that the ruby coil unintentionally detached inside a 0.027 microcatheter (a non-penumbra device).Evaluation of the returned device revealed that the ruby coil was detached from the pusher assembly and that the ruby coil was intact.A non-penumbra wire was returned; however, the pusher assembly for the ruby coil and the microcatheter used in the procedure were not returned for a complete evaluation.Without the return of the pusher assembly, we are unable to determine and/or confirm if a premature detachment occurred.It is also unknown if there was any damage to the 0.027 microcatheter prior to the premature detachment.The root 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: 4346581
• MDR Text Key: 5203547
• Report Number: 3005168196-2014-00871
• 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: 11/18/2014

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: RBY2C2060
• Device Lot Number: F44307
• 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: 03/06/2015
• Initial Date FDA Received: 12/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2014
• 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: 62 YR