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

Catalog Number RH1

Device Problem Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Date 01/07/2019

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.The reported complaint involves the sterility of devices after removal from their packagings during preparation for the procedure.Sterility of a contaminated device cannot be confirmed in the evaluation lab and does not involve manufacturing records; therefore, an investigation will not be performed.This report is associated with mfr report number: 3005168196-2019-00210.

Event Description

During preparation for a coil embolization procedure, a lantern delivery microcatheter (lantern) and ruby coil detachment handle (handle) were accidentally contaminated upon opening of their respective packaging.The lantern and handle were contaminated prior to use and, therefore, were not used in the procedure.The procedure was completed using a new lantern and handle.

• Brand Name: RUBY COIL DETACHMENT HANDLE
• 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: 8321240
• MDR Text Key: 135697164
• Report Number: 3005168196-2019-00211
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013268
• UDI-Public: 00814548013268
• Combination Product (y/n): Y
• 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: 01/01/2005,01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2021
• Device Catalogue Number: RH1
• Device Lot Number: F83897
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2018
• 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: 59 YR