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

Catalog Number RBY4C0860

Device Problems Unsealed Device Packaging (1444); Device Damaged Prior to Use (2284)

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

Event Date 01/13/2015

Event Type  malfunction  

Manufacturer Narrative

Result: the ruby coil sterile pouch was opened.The ruby coil was stretched.The proximal constraint sphere was inside the distal detachment tip (ddt).The pet lock was intact on the proximal end of the pusher assembly.Conclusion: the complaint has been evaluated.The complaint indicates that the first ruby coil sterile pouch was noticed as unsealed upon removal from the product box.The complaint also states that the second ruby coil unraveled inside of a microcatheter.Evaluation of the returned product revealed that the ruby coil was unraveled and that the sterile pouch of the 2nd ruby coil was opened.The opening on this sterile pouch should have been visible during the packaging process and inspection.The cause of this complaint cannot be determined.Evaluation of the ruby coil that unraveled inside the microcatheter confirms that the coil was stretched.This type of damage typically occurs if distal portion of the coil was contained while the coil was being retracted.These devices are 100% visually inspected during process inspection and packaging inspection.These device are also 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.

Event Description

The patient was undergoing a coil embolization procedure using ruby coils.Upon opening a ruby coil, it was noticed that the packaging was not entirely sealed shut and was not used.While advancing another ruby coil, the physician noticed the ruby coil had become damaged in the catheter.The catheter was removed from the patient with the ruby coil still in it.The procedure continued successfully.There was not 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.This mdr is associated with mdr 3005168196-2015-00116.

• 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: 4513758
• MDR Text Key: 12949051
• Report Number: 3005168196-2015-00117
• 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: 01/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: RBY4C0860
• Device Lot Number: F60556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2014
• 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: 23 YR