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

Catalog Number RBY2C2060

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 01/09/2014

Event Type  malfunction  

Event Description

The patient was undergoing an embolization procedure using a ruby coil.During the procedure, the technician opened the box and found the seal on the product pouch to be broken.

Manufacturer Narrative

Result: the sterile pouch was opened at the top where the chevron is located.Conclusion: the device was returned for analysis and has been evaluated.The complaint states that the technician opened the box and found the seal on the sterile pouch was broken.Evaluation of the returned product confirmed that the sterile pouch was opened at the top where the chevron is located.The device is otherwise undamaged.The seal at the top of the sterile pouch is sealed by the manufacturer.The pouches are 100% visually inspected prior to boxing per the device processing instructions.The root cause of this complaint cannot be determined.Future events of this type will be tracked.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, NRY
• 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 ; 5107483262
• MDR Report Key: 3623346
• MDR Text Key: 4204818
• Report Number: 3005168196-2014-00086
• 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
• Report Date: 01/13/2014

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: 12/31/2017
• Device Catalogue Number: RBY2C2060
• Device Lot Number: F31633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2014
• Initial Date FDA Received: 02/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2012
• 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