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

Catalog Number RBY4C0860-A

Device Problems Out-Of-Box Failure (2311); Material Protrusion/Extrusion (2979)

Patient Problem No Patient Involvement (2645)

Event Date 11/18/2015

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

During preparation for a coil embolization procedure, the hospital staff found that a ruby coil was outside of its introducer sheath upon removal from the packaging.This was found prior to use and the ruby coil was not used for the procedure.The procedure successfully continued using a new ruby coil.

Manufacturer Narrative

Result: the pet lock was intact on the proximal end of the ruby coil pusher assembly; the pusher assembly was kinked approximately 35.0 cm from the proximal end; the coil was intact with the pusher assembly.Conclusion: evaluation of the returned device revealed that the ruby coil's embolization coil was advanced outside its introducer sheath and the pusher assembly was kinked.The root cause of the ruby coil being advanced outside of its introducer sheath could not be determined.If the embolization coil was unsheathed during the manufacturing and prior to the packaging process, difficulty would have been experienced while loading the ruby coil into the packaging hoop.The kink in the pusher assembly was likely incidental damage that may have occurred during packaging the device for return.Ruby coils are 100% functionally tested during in-process inspection.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, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5308769
• MDR Text Key: 33828672
• Report Number: 3005168196-2015-01296
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013213
• UDI-Public: 00814548013213
• 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,Followup
• Report Date: 11/18/2015

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: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: RBY4C0860-A
• Device Lot Number: F63707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2016
• Initial Date FDA Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2015
• 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