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

Catalog Number RBY2C2060

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 11/12/2014

Event Type  malfunction  

Manufacturer Narrative

Result: the pet lock was intact with the pusher assembly; the pusher assembly was kinked in multiple locations, and the coil was intact with the pusher assembly.The outer diameter of the coil and distal detachment tip (ddt) were measured and found to be within specification.Conclusion: the complaint has been evaluated.The compliant indicated that the patient was undergoing a coil embolization procedure using a ruby coil.During the procedure, the physician experienced difficultly forming two coils (7x40 and 8x25) due to high blood flow.Both coils were removed for later use in the procedure; however one of the coils (7x40) would not pull back completely into the sheath.The physician was able to use a pod8 successfully during the coil embolization.As the physician attempted to reload one of the previously used coils (8x25), the physician decided not to use it due to the blood and stickiness.Another ruby coil (20x60) was used; however, would not load into the px slim delivery microcatheter.The microcatheter was checked for kinks, it was flushed, and a guide wire was passed through it; however, no issue was noted.Evaluation of the returned device revealed that the pusher assembly had multiple kinks in the hypo-tube; however, the 7x40 coil involved in this complaint was not returned for evaluation as it was disposed of.The noted damage along the hypo-tube typically occurs from packaging the device to be returned for evaluation.Due to the damage in the pusher assembly penumbra's investigators were unable to confirm the issue in the complaint.The outer diameter of the coil and distal detachment tip (ddt) were measured and found to be within specification.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.

Event Description

The patient was undergoing a coil embolization procedure using a ruby coil.During the procedure, the physician experienced difficultly forming two ruby coils (7x40 and 8x25) due to high blood flow.Both coils were removed for a later use in the procedure; however one of the coils (7x40) would not pull back completely into the sheath.The physician was able to use a pod8 successfully.As the physician attempted to reload one of the previous coils (8x25), the physician decided not to use it due to the blood and stickiness.Another ruby coil (20x60) was used; however, would not load into the px slim delivery microcatheter.The microcatheter was checked for kinks, was flushed, and a guide wire was passed through it; however, no issue was noted.The procedure continued using different ruby coils through the same microcatheter.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.This mdr is associated with mdr 3005168196-2014-00859.

• 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: 4327173
• MDR Text Key: 13221477
• Report Number: 3005168196-2014-00860
• 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: 11/12/2014

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: RBY2C2060
• Device Lot Number: F44891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2015
• Initial Date FDA Received: 12/12/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2014
• 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: 75 YR