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

Catalog Number RBY4C0630-A

Device Problems Out-Of-Box Failure (2311); Separation Failure (2547); Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2016

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.Please note that after follow-up attempts for additional clarification, the manufacturer could not determine which lot numbers corresponded to the two ruby coils that were reportedly found outside of their introducer sheaths and which lot number corresponded to the ruby coil that could not be detached in the patient.Therefore, the same device codes will be provided in this report and the associated reports listed below.This report is associated with mfr report numbers: 3005168196-2016-00365; 3005168196-2016-00366.

Event Description

During preparation for a coil embolization procedure, while removing two ruby coils from their sterile packaging, the physician noticed that both coils were outside of their orange introducer sheaths.Therefore, both ruby coils were not used for the procedure.During the procedure, the physician deployed a new ruby coil into the aneurysm using another manufacturer''s microcatheter; however, the ruby coil failed to detach using the detachment handle (handle).The physician removed the ruby coil from the patient and completed the procedure using new ruby coils and the same handle.There was no report of an adverse effect to the patient.

• 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: 5526789
• MDR Text Key: 41221301
• Report Number: 3005168196-2016-00367
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013190
• UDI-Public: 00814548013190
• 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: 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/15/2023
• Device Catalogue Number: RBY4C0630-A
• Device Lot Number: F65716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2015
• 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