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

Catalog Number RBY2C0630

Device Problems Structural Problem (2506); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2015

Event Type  malfunction  

Manufacturer Narrative

Results: the pet lock was intact.The ruby coil pusher assembly was kinked approximately 5.0, 30.0, 54.0, and 107.0 cm from the proximal end.The coil was attached to the distal detachment tip (ddt), and compressed away from the proximal constraint sphere.The coil was damaged throughout the length.Conclusions: evaluation of the returned device revealed that the coil was compressed and the overall coil structure was compromised.This type of damage typically occurs due to improper handling during use.If the ruby coil is manipulated with force at an angle, it is likely that this type of damage could occur.Despite the structural damage to the coil, the coil shaped properly when introduced into body temperature water.The root cause of this complaint could not be determined.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 an embolization procedure using ruby coils.During the procedure, while the physician was deploying a ruby coil in the patient, the coil would not shape properly in the target vessel.Therefore, the ruby coil was withdrawn through the px slim delivery catheter (px slim) and the procedure was completed using a new ruby coil and the same px slim without any further issues.There was no report of any adverse event on the patient.

Manufacturer Narrative

Additional information: (b)(6).

• Brand Name: RUBY COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5841722
• MDR Text Key: 51003467
• Report Number: 3005168196-2016-01143
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548012940
• UDI-Public: 00814548012940
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: RBY2C0630
• Device Lot Number: F61049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2014
• 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: 74 YR