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

Catalog Number RBY2C2860-A

Device Problems Kinked (1339); Device Damaged Prior to Use (2284); Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Date 02/14/2018

Event Type  malfunction  

Manufacturer Narrative

The ruby coil pusher assembly was kinked approximately 97.0, 100.0 and 101.0 cm from its proximal end.Evaluation of the returned ruby coil revealed kinks in close proximity on the pusher assembly.These kinks were likely due to forcefully gripping and advancing the coil against resistance.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

While preparing a ruby coil for a coil embolization procedure, a hospital staff inadvertently kinked the ruby coil pusher assembly while loading the coil into a lantern delivery microcatheter (lantern) on the back table.The kinking of the ruby coil occurred prior to use and therefore, the ruby coil was not used in the procedure.The procedure was completed using a new ruby coil and the same lantern.

• Brand Name: RUBY COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7328525
• MDR Text Key: 102100517
• Report Number: 3005168196-2018-00530
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013091
• UDI-Public: 00814548013091
• 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: Physician
• Type of Report: Initial
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBY2C2860-A
• Device Lot Number: F78562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2017
• 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